FDA 510(k) Applications for Medical Device:
Transmitters And Receivers, Electrocardiograph, Telephone
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K010791 | ADSIS LTD. |
555 THIRTEENTH ST. NW | WASHINGTON | DC | 20004-1109 |
| K132206 | ADVANCED FLUIDICS, LLC |
1468 HARWELL AVE | CROFTON | MD | 21114 |
| K051544 | ADVANCED MONITORING CAREGIVING INC. |
377 ROUTE 17 S | HASBROUCK HEIGHTS | NJ | 07604 |
| K000775 | AEROTEL MEDICAL SYSTEMS (1998) LTD. |
377ROUTE 17 S | HASBROUCK HEIGHT | NJ | 07604 |
| K032736 | AEROTEL MEDICAL SYSTEMS (1998) LTD. |
377 ROUTE 17 | HASBROUCK HEIGHTS | NJ | 07604 |
| K022073 | AEROTEL MEDICAL SYSTEMS (1998) LTD. |
377ROUTE 17 S | HASBROUCK HEIGHT | NJ | 07604 |
| K023418 | AEROTEL MEDICAL SYSTEMS (1998) LTD. |
377 ROUTE 17 | HASBROUCK HEIGHTS | NJ | 07604 |
| K961362 | AEROTEL, LTD. |
201 ROUTE 17 | RUTHERFORD | NJ | 07070 |
| K953762 | AEROTEL, LTD. |
5 HAZOREF ST. | ISRAEL | ||
| K980144 | AEROTEL, LTD. |
377 RT. 17 S | HASBROUCK | NJ | 07604 |
| K983626 | ALARIS MEDICAL SYSTEMS, INC. |
7431 N.W. EVERGREEN PKWY. | HILLSBORO | OR | 97124-5898 |
| K171816 | AliveCor, Inc |
444 Castro Street, Suite 600 | Mountain View | CA | 94041 |
| K140933 | ALIVECOR, INC. |
30 MAIDEN LANE, 6TH FLOOR | SAN FRANCISCO | CA | 94108 |
| K142672 | ALIVECOR, INC. |
30 MAIDEN LANE, 6TH FLOOR | SAN FRANCISCO | CA | 94108 |
| K142743 | AliveCor, Inc. |
30 Maiden Lane, 6th Floor | San Francisco | CA | 94108 |
| K220350 | AliveCor, Inc. |
189 N. Bernardo Ave. Suite 100 | Mountain View | CA | 94043 |
| K210753 | AliveCor, Inc. |
444 Castro Street, Suite 600 | Mountain View | CA | 94041 |
| K211668 | AliveCor, Inc. |
444 Castro Street, Suite 600 | Mountain View | CA | 94041 |
| K182396 | AliveCor, Inc. |
444 Castro Street, Suite 600 | Mountain View | CA | 94041 |
| K191406 | AliveCor, Inc. |
444 Castro Street, Suite 600 | Mountain View | CA | 94041 |
| K183319 | AliveCor, Inc. |
444 Castro Street, Suite 600 | Mountain View | CA | 94041 |
| K173248 | Bioserenity SAS |
47 boulevard de l'Hopital | Paris | 75013 | |
| K172311 | Biotricity Inc. |
275 Shoreline Drive, Suite 150 | Redwood City | CA | 94065 |
| K040942 | BIOWATCH MEDICAL, INC. |
1233 WASHINGTON STREET | COLUMBIA | SC | 29201-3221 |
| K982034 | BLAKBAG, LTD., DIVISION OF COHERENT SYSTEMS |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071-3404 |
| K981394 | BRAEMAR CORP. |
11481 RUPP DR. | BURNSVILLE | MN | 55337 |
| K963725 | CARD GUARD LTD. |
2 PEKERIS ST. | REHOVOT | 76100 | |
| K963811 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
6156 EAST GREENWAY LN. | SCOTTSDALE | AZ | 85254 |
| K954350 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
6156 EAST GREENWAY LN. | SCOTTSDALE | AZ | 85254 |
| K000225 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST., SCIENCE PARK | REHOVOT | 76100 | |
| K990478 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST. | REHOVOT | 76100 | |
| K964836 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
12 HACHOMA ST. | RISHON LE-ZION | 75655 | |
| K994009 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST. | REHOVOT | 76100 | |
| K012223 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST. | REHOVOT | 76100 | |
| K012187 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST., SCIENCE PARK | REHOVOT | 76100 | |
| K023689 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST. | REHOVOT | 76100 | |
| K060911 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST. | REHOVOT | 76100 | |
| K993799 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST. | REHOVOT | 76100 | |
| K052556 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST. | REHOVOT | 76100 | |
| K992696 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST. | REHOVOT | 76100 | |
| K083174 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST., SCIENCE PARK | REHOVOT | 76100 | |
| K983026 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST. | REHOVOT | 76100 | |
| K003220 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST. | REHOVOT | 76100 | |
| K050940 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PERERIS ST., SCIENCE PARK | REHOVOT | 76100 | |
| K042254 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PERERIS ST., SCIENCE PARK | REHOVOT | 76100 | |
| K991307 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST. | REHOVOT | 76100 | |
| K992164 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST. | REHOVOT | 76100 | |
| K013175 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST. | REHOVOT | 76100 | |
| K013879 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST. | REHOVOT | 76100 | |
| K024365 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PERERIS ST., SCIENCE PARK | REHOVOT | 76100 | |
| K170506 | Cardiac Designs, Inc. |
25510 Interstate 45 N | Spring | TX | 77386 |
| K122184 | CARDIAC DESIGNS, LLC |
3293 NIBLICK DRIVE | PARK CITY | UT | 84098 |
| K954163 | CARDIAC EVALUATION CENTER, INC. |
2063 SOUTH 116TH ST. | MILWAUKEE | WI | 53227 |
| K181310 | CardioComm Solutions, Inc. |
259 Yorkland Road, Suite 200 | North York | L0A 1J0 | |
| K172801 | Cardiomedix, Inc. |
1840 Oak Ave. | Evanston | IL | 60201 |
| K050951 | CIBERNET SYSTEMS CORP. |
727 AIRPORT BOULEVARD | ANN ARBOR | MI | 48108 |
| K182040 | Coala Life AB |
Riddargatan 18 | Stockholm | 114 51 | |
| K133703 | COMMWELL R&D LTD. |
555 THIRTEENTH STREET NW | WASHINGTON | DC | 20004 |
| K082077 | CORSCIENCE GMBH & CO. KG |
700-706 SECO RD | MONROEVILLE | PA | 15146 |
| K020534 | CYBERNET MEDICAL |
727 AIRPORT BLVD. | ANN ARBOR | MI | 48108 |
| K971650 | DATA CRITICAL CORP. |
9223 ILONA LN. | HOUSTON | TX | 77025-4218 |
| K042022 | DATRIX, INC. DBA OF JON BARRON, INC. |
340 STATE PLACE | ESCONDIDO | CA | 92029 |
| K971696 | DEL MAR AVIONICS |
1621 ALTON PKWY. | IRVINE | CA | 92606-4801 |
| K051960 | DEL MAR REYNOLDS MEDICAL, LTD. |
377 ROUTE 17 S | HASBROUCK HEIGHTS | NJ | 07604 |
| K062397 | DEL MAR REYNOLDS MEDICAL, LTD. |
377 ROUTE 17 S | HASBROUCK HEIGHTS | NJ | 07604 |
| K072385 | DIAGNOSTIC DEVICES PTY LTD |
SUITE 405 OFFICE TOWER | EASTGARDENS | 2036 | |
| K193296 | eCordum, Inc. |
419 1st Street | East Northport | NY | 11731 |
| K121628 | EPI MOBILE HEALTH SOLUTIONS (S) PTE LTD |
1200 19TH STREET, NW | WASHINGTON | DC | 20032 |
| K173589 | G-Medical Innovations Ltd. |
5 Openheimer St, Park Rabin | Rehovot | 7670105 | |
| K170181 | G-Medical Innovations Ltd. |
5 Openheimer St., Park Rabin | Rehovot | 7670105 | |
| K012012 | H&C MEDICAL DEVICES SPA |
VIA PISA 250 | SESTO SAN GIOVANNI | 20099 | |
| K973267 | HDS MEDICAL, INC. |
2 FAIRE WINDS | LANGUNA NIGUEL | CA | 92677 |
| K142476 | HealthWatch Ltd. |
6 Hasadna Street | Kfar Saba | 44424 | |
| K963904 | HEART ALERT, INC. |
6140 CENTRAL CHURCH RD. | DOUGLASVILLE | GA | 30135 |
| K973863 | HI-TRONICS DESIGNS, INC. |
58 RT. 46 WEST | BUDD LAKE | NJ | 07828 |
| K010945 | INSTROMEDIX |
6779 MESA RIDGE RD., SUITE 200 | SAN DIEGO | CA | 92121-2909 |
| K955060 | INSTROMEDIX, INC. |
7431 N.E. EVERGREEN PKWY., | HILLSBORO | OR | 97124-5898 |
| K964036 | INSTROMEDIX, INC. |
7431 N.E. EVERGREEN PKWY., | HILLSBORO | OR | 97124-5898 |
| K951096 | INSTROMEDIX, INC. |
ONE TECHNOLOGY CENTER | HILLSBORO | OR | 97124-5898 |
| K081471 | IRHYTHM TECHNOLOGIES, INC. |
650 TOWNSEND STREET | SAN FRANCISCO | CA | 94103 |
| K052767 | LECHNOLOGIES RESEARCH INC. |
N. 64 W. 24801 MAIN ST. | SUSSEX | WI | 53089 |
| K201208 | LIVMOR |
16470 Bake Pkwy., Ste. 200 | Irvine | CA | 92618 |
| K130878 | MAKROMED, INC. |
88 STILES ROAD | SALEM | NH | 03079 |
| K060297 | MEDICAL MONITORS LTD |
SUITE 407 OFFICE TOWER | WESTFIELD EAST GARDENS | NSW 2036 | |
| K030218 | MEDICAL MONITORS PTY., LTD. |
SUITE 407, OFFICE TOWERS | EAST GARDENS, NSW | 2036 | |
| K981119 | MEDICOMP, INC. |
7845 ELLIS RD. | WEST MELBOURNE | FL | 32904 |
| K131699 | MEGA ELECTRONICS LTD. |
Prinsessegracht 20 | The Hague | 2514 AP | |
| K143032 | MEGA ELECTRONICS LTD. |
PIONEERINKATU 6 | KUOPIO | 70800 | |
| K983582 | MERDIAN MEDICAL TECHNOLOGIES LTD. |
25 RANDALSTOWN ROAD | ANTRIUM | BT41 4LJ | |
| K010794 | MERIDIAN MEDICAL TECHNOLOGIES LTD. |
207 AIRPORT RD., WEST | BELFAST | BT3 9ED | |
| K002310 | MERIDIAN MEDICAL TECHNOLOGIES LTD. |
207 AIRPORT RD., WEST | BELFAST | BT3 9ED | |
| K965101 | MERIDIAN MEDICAL TECHNOLOGIES, INC. |
49 PLAIN ST. | N. ATTLEBORO | MA | 02760 |
| K970305 | MICROMEDICAL, INC. |
255 REVERE DR., SUITE 111 | NORTHBROOK | IL | 60062 |
| K161431 | Nanowear Inc. |
53 Boerum Place | Brooklyn | NY | 11201 |
| K201669 | Nanowear Inc. |
53 Boerum Place, Suite 3F | Brooklyn | NY | 11201 |
| K212160 | Nanowear Inc. |
53 Boerum Place, Suite 3F | Brooklyn | NY | 11201 |
| K001091 | NEXT MILLENNIUM SOFTWARE SOLUTIONS, INC. |
7224 WEST 29TH WAY | HIALEAH | FL | 33018 |
| K973141 | PACEART, INC. |
377 ROUTE 17 SOUTH | HASBROUCK HEIGHTS | NJ | 07604 |
| K952065 | PACEART, INC. |
22 RIVERVIEW DR. | WAYNE | NJ | 07470 |
| K982090 | PACEART, INC. |
377 ROUTE 17 SOUTH | HASBROUCK HEIGHTS | NJ | 07604 |
| K012407 | PACEART, INC. |
377 ROUTE 17 SOUTH | HASBROUCK HEIGHTS | NJ | 07604 |
| K061977 | PINMED, INC |
245 MELWOOD AVE, #501 | PITTSBURG | PA | 15213 |
| K093976 | PROTEUS BIOMEDICAL, INC. |
2600 BRIDGE PARKWAY | REDWOOD CITY | CA | 94065 |
| K173872 | Qompium nv |
Kempische Steenweg 311/27 | Hasselt | 3500 | |
| K180157 | QT Medical, Inc. |
1001 W Carson Street | Torrance | CA | 90502 |
| K220795 | QT Medical, Inc. |
1360 Valley Vista Drive, Suite 203 | Diamond Bar | CA | 91765 |
| K010436 | REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
THE AVENUE, FARLEIGH WALLOP | BASINGSTOKE, HAMPSHIRE | RG25 2HT | |
| K033410 | REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
THE OLD COACH HOUSE, THE AV. | HAMPSHIRE | RG25 2HT | |
| K082718 | REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
THE AVENUE, FARLEIGH WALLOP | BASINGSTOKE, HAMPSHIRE | RG25 2HT | |
| K972649 | REYNOLDS MEDICAL LTD. |
377 RT. 17 S. | HASBROUCK HEIGHTS | NJ | 07604 |
| K011345 | REYNOLDS MEDICAL LTD. |
377 RT. 17 S. | HASBROUCK HEIGHTS | NJ | 07604 |
| K991211 | REYNOLDS MEDICAL LTD. |
1-2 HARFORDE CT., FOXHOLES | HERTFORD | SG13 7NW | |
| K141813 | RHYTHMEDIX, LLC |
5353 WAYZATA BLVD, SUITE 505 | MINNEAPOLIS | MN | 55416 |
| K992772 | RLT MEDICAL ASSOC., INC. |
9620 DEERECO RD. | TIMONIUM | MD | 21093 |
| K020213 | ROZINN ELECTRONICS, INC. |
71-22 MYRTLE AVE. | GLENDALE | NY | 11385 |
| K061780 | ROZINN ELECTRONICS, INC. |
71-22 MYRTLE AVE. | GLENDALE | NY | 11385 |
| K222842 | Shandong CoreCare Technology Limited |
Suite 801-2, Incubator Phase I, Innovation Valley, | Jinan | ||
| K080047 | SHL TELEMEDICINE INTERNATIONAL LTD. |
31 HAAVODA ST. | BINYAMINA | 30500 | |
| K063609 | SHL TELEMEDICINE INTERNATIONAL LTD. |
291 HILLSIDE AVE. | SOMERSET | MA | 02726 |
| K113514 | SHL TELEMEDICINE INTERNATIONAL LTD. |
31 HAAVODA ST. | BINYAMINA | 30500 | |
| K071228 | SIGNALIFE, INC. |
531 SOUTH MAIN ST. | GREENVILLE | SC | 29601 |
| K083630 | TELOVITAL GMBH TELEMEDIZIN |
901 KING ST., SUITE 200 | ALEXANDRIA | VA | 22314 |
| K031229 | TELZUIT TECHNOLOGIES, INC. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K053378 | TMS TELEMEDIZINISCHE SYSTEME GMBH |
STADLERSTRASSE 14 | CHEMNITZ | D-09126 | |
| K050670 | TMS TELEMEDIZINISCHE SYSTEME GMBH |
STADLERSTRASSE 14 | CHEMNITZ | 09126 | |
| K001634 | TZ MEDICAL, INC. |
15858 S.W. UPPER BOONES FERRY | LAKE OSWEGO | OR | 97035 |
| K982228 | TZ MEDICAL, INC. |
15858 S.W. UPPER BOONES FERRY | LAKE OSWEGO | OR | 97035 |
| K964888 | TZ MEDICAL, INC. |
15858 S.W. UPPER BOONES FERRY | LAKE OSWEGO | OR | 97035 |
| K980624 | UNIVERSAL MEDICAL, INC. |
1608 WALNUT ST. | PHILADELPHIA | PA | 19103 |
| K071130 | UNIVERSAL MEDICAL, INC. |
275 PHILLIPS BLVD. | EWING | NJ | 08618 |
| K033451 | UNIVERSAL MEDICAL, INC. |
ONE COMMERCE SQUARE | PHILADELPHIA | PA | 19103 |
| K083535 | UNIVERSAL MEDICAL, INC. |
275 PHILLIPS BLVD. | EWING | NJ | 08618 |
| K960499 | UNIVERSAL MEDICAL, INC. |
1760 MARKET ST. | PHILADELPHIA | PA | 19103 |
| K954495 | UNIVERSAL MEDICAL, INC. |
1760 MARKET ST. | PHILADELPHIA | PA | 19103 |
| K182456 | Verily Life Sciences LLC |
269 E Grand Avenue | South San Francisco | CA | 94080 |
| K192415 | Verily Life Sciences LLC |
269 E Grand Avenue | South San Francisco | CA | 94080 |
| K213357 | Verily Life Sciences LLC |
269 East Grand Avenue | South San Francisco | CA | 94080 |
| K963375 | VISION ELECTRONICS |
4 DAISY LN. | KIRKWOOD | NY | 13795 |
| K962937 | VISION ELECTRONICS |
4 DAISY LN. | KIRKWOOD | NY | 13795 |
| K151013 | Vitasystems GmbH |
Stadlerstrasse 14 | Chemnitz | D-09126 | |
| K100383 | VITASYSTEMS GMBH |
STADLERSTRASSE 14 | CHEMNITZ | 09126 | |
| K183704 | VivaQuant Inc. |
4339 Nancy Place, Suite 100 | St. Paul | MN | 55126 |
| K041308 | WEBVMC, LLC |
1308 MORNINGSIDE PARK DRIVE | ALPHARETTA | GA | 30022 |
| K002004 | ZYMED MEDICAL INSTRUMENTATION |
1201 B NORTH RICE AVE. | OXNARD | CA | 93030 |
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