FDA 510(k) Applications for Medical Device:
Detector And Alarm, Arrhythmia
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K980186 | AGILENT TECHNOLOGIES |
20 NORTH AVIADOR ST. | CAMARILLO | CA | 93010 |
| K990093 | AGILENT TECHNOLOGIES |
20 NORTH AVIADOR ST. | CAMARILLO | CA | 93010 |
| K002758 | AGILENT TECHNOLOGIES DEUTSCHLAND GMBH |
HERRENBERGER ST. 130 | BOEBLINGEN, | 71034 | |
| K001333 | AGILENT TECHNOLOGIES DEUTSCHLAND GMBH |
HERRENBERGER ST. 130 | BOEBLINGEN, | 71034 | |
| K000822 | AGILENT TECHNOLOGIES, GMBH |
HERRENBERGERSTR. 130 | BOEBLINGEN | 71034 | |
| K001057 | AGILENT TECHNOLOGIES, INC. |
3000 MINUTEMAN RD. | ANDOVER | MA | 01810-1099 |
| K001436 | AGILENT TECHNOLOGIES, INC. |
3000 MINUTEMAN RD. | ANDOVER | MA | 01810-1099 |
| K011824 | AGILENT TECHNOLOGIES, INC. |
3000 MINUTEMAN RD. | ANDOVER | MA | 01810-1099 |
| K050919 | ANALOGIC CORP. |
8 CENTENNIAL DR. | PEABODY | MA | 01960 |
| K100155 | BIOMEDICAL SYSTEMS CORP. |
77 PROGRESS PARKWAY | ST. LOUIS | MO | 63043 |
| K153473 | Braemar Manufacturing, LLC |
3890 Murphy Canyon Road, Suite 100 | San Diego | CA | 92123 |
| K081444 | BRAEMAR, INC. |
1285 CORPORATE CENTER DR. | EAGAN | MN | 55121 |
| K955023 | BRENTWOOD MEDICAL PRODUCTS, INC. |
3555 LOMITA BLVD. STE.E | TORRANCE | CA | 90505 |
| K952417 | BURDICK, INC. |
15 PLUMB ST. | MILTON | WI | 53563-1499 |
| K110499 | CARD GUARD SCIENTIFIC SURVIVAL LTD. |
555 ZANG ST | LAKEWOOD | CO | 80228 |
| K081257 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST., SCIENCE PARK | REHOVOT | 76100 | |
| K101639 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
555 ZANG STREET | LAKEWOOD | CO | 80228 |
| K071995 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST. P.O. BOX 527 | REHOVOT | 76101 | |
| K101703 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
555 ZANG STREET | LAKEWOOD | CO | 80228 |
| K935732 | CARDIO CONTROL BV |
PARTRIJSWEG 72 | THE NETHERLANDS | ||
| K012241 | CARDIONET, INC |
510 MARKET ST. | SAN DIEGO | CA | 92101 |
| K053263 | CARDIONET, INC |
1010 2ND AVE., SUITE 700 | SAN DIEGO | CA | 92101 |
| K140548 | CORCAM TECHNOLOGIA, SA |
575 EIGHTH AVE, STE 1212 | NEW YORK | NY | 10018 |
| K083287 | CORVENTIS, INC. |
2226 N. FIRST STREET | SAN JOSE | CA | 95131 |
| K091971 | CORVENTIS, INC. |
2033 GATEWAY PLACE | SAN JOSE | CA | 95110 |
| K071805 | DATASCOPE CORP. |
800 MACARTHUR BLVD. | MAHWAH | NJ | 07430-0619 |
| K993531 | DATASCOPE CORP. |
580 WINTERS AVE. | PARAMUS | NJ | 07652 |
| K020550 | DATASCOPE CORP. |
800 MACARTHUR BLVD. | MAHWAH | NJ | 07430-0619 |
| K974747 | DATEX-ENGSTROM, INC. |
2 HIGHWOOD DR. | TEWKSBURY | MA | 01876 |
| K974792 | DATEX-ENGSTROM, INC. |
2 HIGHWOOD DR. | TEWKSBURY | MA | 01876 |
| K021376 | DATEX-OHMEDA |
86 PILGRIM RD. | NEEDHAM | MA | 02492 |
| K033305 | Draeger Medical Systems, Inc. |
16 ELECTRONICS AVE. | DANVERS | MA | 01923 |
| K964187 | FUKUDA DENSHI USA, INC. |
55 NORTHERN BLVD., SUITE 410 | GREAT NECK | NY | 11021 |
| K980728 | FUKUDA DENSHI USA, INC. |
17725 N.E. 65TH ST., BLDG. C | REDMOND | WA | 98052-4911 |
| K020084 | FUKUDA DENSHI USA, INC. |
17725 N.E. 65TH ST., BLDG. C | REDMOND | WA | 98052-4911 |
| K970585 | FUKUDA DENSHI USA, INC. |
17725 N.E. 65TH ST., BLDG. C | REDMOND | WA | 98052-4911 |
| K000746 | FUKUDA DENSHI USA, INC. |
17725 N.E. 65TH ST., BLDG. C | REDMOND | WA | 98052-4911 |
| K971131 | FUKUDA DENSHI USA, INC. |
17725 N.E. 65TH ST., BLDG. C | REDMOND | WA | 98052-4911 |
| K963057 | FUKUDA DENSHI USA, INC. |
7102-A 180TH AVENUE NORTHEAST | REDMOND | WA | 98052 |
| K071889 | GE HEALTHCARE |
86 PILGRIM ROAD | NEEDHAM | MA | 02492 |
| K032370 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
8200 WEST TOWER AVE. | MILWAUKEE | WI | 53223 |
| K062976 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
8200 WEST TOWER AVE. | MILWAUKEE | WI | 53223 |
| K000779 | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
8200 WEST TOWER AVE. | MILWAUKEE | WI | 53223 |
| K001359 | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
8200 WEST TOWER AVE. | MILWAUKEE | WI | 53223 |
| K992637 | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
8200 WEST TOWER AVE. | MILWAUKEE | WI | 53223 |
| K993757 | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
8200 WEST TOWER AVE. | MILWAUKEE | WI | 53223 |
| K012467 | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
8200 WEST TOWER AVE. | MILWAUKEE | WI | 53223 |
| K152701 | GLOBAL INSTRUMENTATION, LLC |
8104 CAZENOVIA ROAD | MANLIUS | NY | 13104 |
| K964832 | HEWLETT-PACKARD CO. |
3000 MINUTEMAN RD. | ANDOVER | MA | 01810-1085 |
| K981376 | HEWLETT-PACKARD CO. |
3000 MINUTEMAN RD. | ANDOVER | MA | 01810-1085 |
| K961165 | HEWLETT-PACKARD CO. |
3000 MINUTEMAN RD. | ANDOVER | MA | 01810-1099 |
| K993516 | HEWLETT-PACKARD CO. |
3000 MINUTEMAN ROAD, MS 0491 | ANDOVER | MA | 01810-1099 |
| K980429 | HEWLETT-PACKARD CO. |
3000 MINUTEMAN RD. | ANDOVER | MA | 01810-1085 |
| K964122 | HEWLETT-PACKARD CO. |
3000 MINUTEMAN RD. | ANDOVER | MA | 01810 |
| K993171 | HEWLETT-PACKARD CO. |
3000 MINUTEMAN RD. | ANDOVER | MA | 01810 |
| K991773 | HEWLETT-PACKARD GMBH |
HERRENBERGER STR. 110-140 | BOEBLINGEN | 71034 | |
| K990972 | HEWLETT-PACKARD GMBH |
HERRENBERGER STR. 110-140 | BOEBLINGEN | 71034 | |
| K990125 | HEWLETT-PACKARD GMBH |
HERRENBERGER STR. 110-140 | BOEBLINGEN | 71034 | |
| K993383 | HEWLETT-PACKARD GMBH |
HERRENBERGER STR. 110-140 | BOEBLINGEN | 71034 | |
| K971910 | HEWLETT-PACKARD GMBH |
SCHICKARD STRASSE 4 | WUERTTEMBERG | 71034 | |
| K152491 | INFOBIONIC, INC. |
600 SUFFOLK STREET | LOWELL | MA | 01854 |
| K230265 | InfoBionic, Inc. |
312 Billerica Rd. Office Link #5 | Chelmsford | MA | 02184 |
| K131000 | INTELESENS LIMITED |
24301 WOODSAGE DRIVE | BONITA SPRINGS | FL | 34134 |
| K111160 | INTRICON DATRIX CORPORATION |
962 ALLEGRO LANE | APOLLO BEACH | FL | 33572 |
| K002604 | INVIVO RESEARCH, INC. |
12601 RESEARCH PKWY. | ORLANDO | FL | 32826 |
| K980045 | INVIVO RESEARCH, INC. |
12601 RESEARCH PKWY. | ORLANDO | FL | 32826 |
| K240177 | iRhythm Technologies, Inc. |
699 8th Street | San Francisco | CA | 94103 |
| K972498 | JOHNSON & JOHNSON MEDICAL, INC. |
4110 GEORGE RD. | TAMPA | FL | 33634 |
| K960884 | LIFE SENSING INSTRUMENT COMPANY, INC. |
329 WEST LINCOLN ST. | TULLAHOMA | TN | 37388 |
| K132407 | LIFEWATCH TECHNOLOGIES LTD |
2 PEKERIS STREET | REHOVOT | 7670202 | |
| K143359 | LifeWatch Technologies Ltd. |
2 Pekeris St. | Rehovot | 7670202 | |
| K151269 | LifeWatch Technologies Ltd. |
2 Pekeris St. | Rehovot | 0202 | |
| K151835 | LIFEWATCH TECHNOLOGIES LTD. |
2 PEKERIS ST. | REHOVOT | 7670202 | |
| K962827 | MARQUETTE ELECTRONICS, INC. |
8200 WEST TOWER AVE. | MILWAUKEE | WI | 53223 |
| K960418 | MARQUETTE ELECTRONICS, INC. |
8200 WEST TOWER AVE. | MILWAUKEE | WI | 53223 |
| K961139 | MARQUETTE ELECTRONICS, INC. |
8200 WEST TOWER AVE. | MILWAUKEE | WI | 53223 |
| K954852 | MARQUETTE ELECTRONICS, INC. |
8200 WEST TOWER AVE. | MILWAUKEE | WI | 53223 |
| K970545 | MARQUETTE MEDICAL SYSTEMS, INC. |
8200 WEST TOWER AVE. | MILWAUKEE | WI | 53223 |
| K970012 | MEDICAL DATA ELECTRONICS |
12720 WENTWORTH ST. | ARLETA | CA | 91331 |
| K012336 | MEDICAL DATA ELECTRONICS |
12723 WENTWORTH ST. | ARLETA | CA | 91331 |
| K112921 | MEDICAL.GORITHMICS S.A. |
245 WEST 107TH ST. | NEW YORK | NY | 10025 |
| K124060 | MEDICALGORITHMICS S.A. |
245 WEST 107TH ST. SUITE 11A | NEW YORK | NY | 10025 |
| K152550 | MEDICALGORITHMICS S.A. |
AI. JEROZOLIMSKIE 81 | WARSAW | 02-001 | |
| K173969 | Medicalgorithmics S.A. |
Aleje Jerozolimskie 81 | Warsaw | 02-001 | |
| K193104 | Medicalgorithmics S.A. |
Aleje Jerozolimskie 81 | Warsaw | 02-001 | |
| K090037 | MEDICALGORITHMICS SP Z.O.O. |
245 WEST 107TH STREET | NEW YORK | NY | 10025 |
| K090834 | MEDICOMP, INC. |
55 Northern Blvd. | Great Neck | NY | 11021 |
| K173170 | Medicomp, Inc. |
600 Atlantis Rd | Melbourne | FL | 32904 |
| K071655 | MEDTRONIC INC. |
8200 CORAL SEA STREET NW | MOUNDS VIEW | MN | 55112 |
| K103764 | MEDTRONIC INC. |
8200 CORAL SEA ST NE | MOUNDS VIEW | MN | 55112 |
| K082475 | MEDTRONIC INC. |
8200 CORAL SEA STREET NE | MOUNDS VIEW | MN | 55112 |
| K071641 | MEDTRONIC INC. |
8200 CORAL SEA STREET NW | MOUNDS VIEW | MN | 55112 |
| K190574 | Medtronic, Inc |
8200 Coral Sea Street NE | Mounds View | MN | 55112 |
| K150117 | Medtronic, Inc. |
8200 Coral Sea Street NE | Mounds View | MN | 55112 |
| K181658 | Memtec Corporation |
68 Stiles Road Unit D | Salem | NH | 03079 |
| K001120 | MENNEN MEDICAL LTD. |
KIRYAT WEIZMANN SCIENCE PARK | REHOVOT | 76100 | |
| K141441 | MENNEN MEDICAL LTD. |
4 HA-YARDEN ST. YAVNE 8122804 | YAVNE | 8122804 | |
| K023798 | MENNEN MEDICAL LTD. |
4 HAYARDEN ST., YAVNE | REHOVOT | 76100 | |
| K011784 | MENNEN MEDICAL LTD. |
KIRYAT WEIZMANN | REHOVOT | 76100 | |
| K052288 | MENNEN MEDICAL LTD. |
4 HAYARDEN ST. | YAVNE | 81228 | |
| K093766 | MENNEN MEDICAL LTD. |
4 HA-YARDEN ST. | YAVNE, REHOVOT | 76100 | |
| K073140 | MENNEN MEDICAL LTD. |
4 HAYARDEN ST., YAVNE | REHOVOT | 76100 | |
| K970358 | MENNEN MEDICAL, INC. |
KIRYAT WEIZMANN SCIENCE PARK | REHOVOT | 76100 | |
| K974510 | MENNEN MEDICAL, INC. |
KIRYAT WEIZMANN SCIENCE PARK | REHOVOT | 76100 | |
| K982697 | MENNEN MEDICAL, INC. |
KIRYAT WEIZMANN SCIENCE PARK | REHOVOT | 76100 | |
| K182532 | National Cardiac, Inc. |
221 W. Crest Street Suite 205 | Escondido | CA | 92025 |
| K002068 | NIHON KOHDEN AMERICA, INC. |
90 ICON ST. | FOOTHILL RANCH | CA | 92610-1601 |
| K152305 | NIHON KOHDEN CORPORATION |
1-31-4 NISHIOCHIAI, SHINJUKU-KU | TOKYO | 161-8560 | |
| K113125 | PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD. | ANDOVER | MA | 01810-1099 |
| K021300 | PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD. | ANDOVER | MA | 01810 |
| K021251 | PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD. | ANDOVER | MA | 01810 |
| K070260 | PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD. | ANDOVER | MA | 01810 |
| K014159 | PHILIPS MEDICAL SYSTEMS, INC. |
3000 MINUTEMAN RD. | ANDOVER | MA | 01810-1099 |
| K151681 | PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
HEWLETT-PACKARD STR. 2 | BOEBLINGEN | 71034 | |
| K150310 | PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
HEWLETT-PACKARD STR.2 | BOEBLINGEN | 71034 | |
| K032858 | PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH |
HEWLETT-PACKARD-STR. 2 | BOEBLINGEN | D 71034 | |
| K082633 | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
HEWLETT-PACKARD STR.2 | BOEBLINGEN | D 71034 | |
| K083517 | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
HEWLETT-PACKARD STR.2 | BOEBLINGEN | D 71034 | |
| K091927 | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
HEWLETT-PACKARD STR.2 | BOEBLINGEN | D 71034 | |
| K151188 | PREVENTICE |
2765 COMMERCE DRIVE NW, #220 | ROCHESTER | MN | 55901 |
| K192732 | Preventice Technologies, Inc. |
3052 Hwy52 N, Building 003-2 | Rochester | MN | 55901 |
| K121197 | PREVENTICE, INC. |
2765 COMMERCE DRIVE NW | ROCHESTER | MN | 55901 |
| K003576 | QUINTON, INC. |
3303 MONTE VILLA PKWY. | BOTHELL | WA | 98021-8906 |
| K992908 | QUINTON, INC. |
3303 MONTE VILLA PKWY. | BOTHELL | WA | 98021-8906 |
| K142352 | Ross Medical Technology, Inc |
82 E. ALLENDALE ROAD, SUITE 8A | SADDLE RIVER | NJ | 07458 |
| K964593 | S & W MEDICO TEKNIK A/S |
HERSTEDVANG 8 | ALBERTSLUND | DK-2620 | |
| K142180 | SCOTTCARE CORPORATION |
4791 WEST 150TH ST. | CLEVELAND | OH | 44135 |
| K092947 | SCOTTCARE CORPORATION |
4791 WEST 150TH ST. | CLEVELAND | OH | 44135 |
| K955059 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. | DANVERS | MA | 01923 |
| K982730 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. | DANVERS | MA | 01923 |
| K980882 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. | DANVERS | MA | 01923 |
| K012461 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. | DANVERS | MA | 01923 |
| K031433 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. | DANVERS | MA | 01923 |
| K024213 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
186 S. WOOD AVENUE | ISELIN | NJ | 08830 |
| K003246 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. | DANVERS | MA | 01923 |
| K003179 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. | DANVERS | MA | 01923 |
| K983980 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. | DANVERS | MA | 01923 |
| K980625 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. | DANVERS | MA | 01923 |
| K972714 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. | DANVERS | MA | 01923 |
| K962404 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. | DANVERS | MA | 01923 |
| K955743 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. | DANVERS | MA | 01923 |
| K983632 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. | DANVERS | MA | 01923 |
| K970348 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. | DANVERS | MA | 01923 |
| K962291 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. | DANVERS | MA | 01923 |
| K964624 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. | DANVERS | MA | 01923 |
| K970920 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. | DANVERS | MA | 01923 |
| K974698 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. | DANVERS | MA | 01923 |
| K965062 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. | DANVERS | MA | 01923 |
| K952054 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
16 ELECTRONICS AVE. | DANVERS | MA | 01923 |
| K231276 | SmartCardia SA |
EPFL Innovation Park Building C | Lausanne | 1015 | |
| K011339 | SPACELABS BURDICK, INC. |
20310 SW 48TH ST. | FT. LAUDERDALE | FL | 33332 |
| K103142 | SPACELABS HEALTHCARE, INC. |
PO BOX 3018 | NEDERLAND | CO | 80466 |
| K050605 | SPACELABS MEDICAL INC. |
5150 220TH AVE SE | ISSAQUAH, WA | WA | 98027-7018 |
| K013046 | SPACELABS MEDICAL, INC. |
1730 PENNSYLVANIA AVE. NW | WASHINGTON | DC | 20006 |
| K021097 | SPACELABS MEDICAL, INC. |
1730 PENNSYLVANIA AVE. NW | WASHINGTON | DC | 20006 |
| K962970 | SPACELABS MEDICAL, INC. |
P.O. BOX 97013 | REDMOND | WA | 98073-9713 |
| K952912 | SPACELABS MEDICAL, INC. |
P.O. BOX 97013 | REDMOND | WA | 98073-9713 |
| K972502 | SPACELABS MEDICAL, INC. |
P.O. BOX 97013 | REDMOND | WA | 98073-9713 |
| K050175 | SPACELABS MEDICAL, INC. |
5150 220TH AVE SE | ISSAQUAH | WA | 98027-7018 |
| K972282 | SPACELABS MEDICAL, INC. |
P.O. BOX 97013 | REDMOND | WA | 98073-9713 |
| K102507 | TZ MEDICAL, INC. |
7272 SW DURHAM RD., #800 | PORTLAND | OR | 97224 |
| K153477 | VITASYSTEMS GMBH |
MARKIRCHER STR. 22 | Mannheim | 68229 | |
| K022453 | WELCH ALLYN PROTOCOL, INC. |
8500 S.W. CREEKSIDE PLACE | BEAVERTON | OR | 97008-7107 |
| K120774 | WELCH ALLYN, INC. |
4341 STATE ST. RD. | SKANEATELES FALLS | NY | 13153-0220 |
| K052160 | WELCH ALLYN, INC. |
4341 STATE ST. RD. | SKANEATELES FALLS | NY | 13153-0220 |
| K102111 | WPR MEDICAL AS |
435 RICE CREEK TERRACE | FRIDLEY | MN | 55432 |
| K984089 | ZYMED MEDICAL INSTRUMENTATION |
20 NORTH AVIADOR ST. | CAMARILLO | CA | 93010 |
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