FDA 510(k) Applications for Medical Device:
Electrode, Electrocardiograph
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K970796 | 3M HEALTH CARE |
P.O. BOX 33275 | ST. PAUL | MN | 55144-1000 |
| K974445 | 3M HEALTH CARE |
3M CENTER, BLDG. 275-3E-08 | ST. PAUL | MN | 55133-1000 |
| K971444 | 3M MEDICAL PRODUCTS GROUP |
3M CENTER, BLDG. 275-3E-08 | ST. PAUL | MN | 55144-1000 |
| K043361 | ADVANCED BIOELECTRIC CORPORATION |
2160 JOHNSON STREET | SAINT-LAURENT, QUEBEC | H4M 1M1 | |
| K053550 | AMBU A/S |
6740 BAYMEADOW DR. | GLEN BURNIE | MD | 21060 |
| K100129 | AMBU A/S |
6740 BAYMEADOW DR. | GLEN BURNIE | MD | 21060 |
| K052944 | AMBU A/S |
6740 BAYMEADOW DR. | GLEN BURNIE | MD | 21060 |
| K041026 | AMBU, INC. |
611 NORTH HAMMONDS FERRY ROAD | LINTHICUM | MD | 21090-1356 |
| K041734 | AMBU, INC. |
611 NORTH HAMMONDS FERRY ROAD | LINTHICUM | MD | 21090-1356 |
| K000206 | AXELGAARD MFG. CO., LTD. |
329 WEST AVIATION RD. | FALLBROOK | CA | 92028-3227 |
| K020003 | BIO PROTECH, INC. |
198 AVENUE DE LA D'EMERALD | SPARKS | NV | 89434-9550 |
| K053011 | BIO PROTECH, INC. |
1676 VILLAGE GREEN SUITE A | CROFTON | MD | 21114 |
| K040784 | BIO PROTECH, INC. |
1676 VILLAGE GREEN SUITE A | CROFTON | MD | 21114 |
| K083148 | BIO PROTECH, INC. |
1720-26 TAEJANG 2-DONG, WONJU | WOONJU-SI, GANGWON-DO | ||
| K964213 | BIO-DETEK, INC. |
525 NARRAGANSETT PARK DR. | PAWTUCKET | RI | 02861-4323 |
| K962115 | CAMBRIDGE HEART, INC. |
ONE OAK PARK DR. | BEDFORD | MA | 01730 |
| K002230 | CAMBRIDGE HEART, INC. |
20310 SW 48TH ST. | FT. LAUDERDALE | FL | 33332 |
| K090496 | CARDIAC LEAD TECHNOLOGIES, INC. |
575 7TH ST. NW | WASHINTON | DC | 20004 |
| K963159 | CMC SENSE-IT, INC. |
810 SOUTH 1ST STREET, #120 | HOPKINS | MN | 55343 |
| K955815 | CMC SENSE-IT, INC. |
810 SOUTH 1ST. ST. #120 | HOPKINS | MN | 55343 |
| K955800 | CMC SENSE-IT, INC. |
810 SOUTH 1ST. ST. #120 | HOPKINS | MN | 55343 |
| K083677 | COMMWELL LTD. |
555 THIRTEENTH ST., NW | WASHINGTON | DC | 20004-1109 |
| K954388 | CONMED CORP. |
P.O. BOX 1408 | DAYTON | OH | 45401-1408 |
| K954389 | CONMED CORP. |
310 BROAD ST. | UTICA | NY | 13501-1203 |
| K960264 | CONMED CORP. |
P.O. BOX 1408 | DAYTON | OH | 45401-1408 |
| K991105 | CONMED CORP. |
310 BROAD ST. | UTICA | NY | 13501-1203 |
| K963787 | CONMED CORP. |
310 BROAD ST. | UTICA | NY | 13501-1203 |
| K091856 | CONMED CORPORATION |
525 FRENCH RD. | UTICA | NY | 13502 |
| K970125 | CONTOUR MEDICAL TECHNOLOGY, INC. |
144 SOUTHWAY BLVD. | LAVERGNE | TN | 37086 |
| K973727 | DON TAY INDUSTRIES |
2383 S. 16ND ST. | NEW BERLIN | WI | 53151 |
| K050248 | ELECTRAMOLD |
3600 CHAMBERLAIN LANE | LOUISVILLE | KY | 40241-1914 |
| K954773 | FERGUSON MEDICAL |
3407 BAY AVE. | CHICO | CA | 95973-8619 |
| K954772 | FERGUSON MEDICAL |
3407 BAY AVE. | CHICO | CA | 95973-8619 |
| K060661 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
8200 WEST TOWER AVE. | MILWAUKEE | WI | 53223 |
| K973663 | GOLDEN GATE BIO-DEVICE |
22030 IDENA AVE. | CASTRO VALLEY | CA | 94546 |
| K960968 | GRAPHIC CONTROLS CORP. |
189 VAN RENSSELAER ST. | BUAFFLO | NY | 14240-1271 |
| K963038 | GRAPHIC CONTROLS CORP. |
189 VAN RENSSELAER ST. | BUAFFLO | NY | 14240-1271 |
| K981964 | GRAPHIC CONTROLS CORP. |
PO BOX 1274 | BUFFALO | NY | 14240 |
| K963151 | GRAPHIC CONTROLS CORP. |
189 VAN RENSSELAER ST. | BUAFFLO | NY | 14240-1271 |
| K961395 | GRAPHIC CONTROLS CORP. |
189 VAN RENSSELAER ST. | BUAFFLO | NY | 14240-1271 |
| K140096 | HMICRO, INC. |
4984 EL CAMINO REAL #200 | LOS ALTOS | CA | 94022 |
| K100315 | I NEEDMD, INC |
420 LEXINGTON AVENUE | NEW YORK | NY | 10170 |
| K033559 | INEEDMD |
860 CANAL STREET | STAMFORD | CT | 06902 |
| K030316 | INOVISE MEDICAL, INC. |
1025 INDUSTRIAL PKWY. | NEWBERG | OR | 97132 |
| K080602 | INOVISE MEDICAL, INC. |
10565 SW NIMBUS AVE. | PORTLAND | OR | 97223 |
| K101685 | INTEGRAL PROCESS SAS |
12 RUE DES CAYENNES | CONFLANS SAINTE HONORINE | 78703 | |
| K953649 | KENDALL-LTP |
2 LUDLOW PARK DR. | CHICOPEE | MA | 01022 |
| K050443 | KENTEC MEDICAL, INC. |
20492 CRESCENT BAY DR | LAKE FOREST | CA | 92630 |
| K024264 | LEONHARD LANG CO. |
P.O. BOX 560 | STILLWATER | MN | 55082-0560 |
| K982521 | LEONHARD LANG CO. |
ARCHENWEG 56 | INNSBRUCK | A-6010 | |
| K023920 | LEONHARD LANG GMBH |
P.O. BOX 560 | STILLWATER | MN | 55082-0560 |
| K073104 | LEONHARD LANG GMBH |
P.O. BOX 560 | STILLWATER | MN | 55082-0560 |
| K092291 | LEONHARD LANG GMBH |
P.O. BOX 560 | STILLWATER | MN | 55082-0560 |
| K023503 | LEONHARD LANG GMBH |
P.O. BOX 560 | STILLWATER | MN | 55082-0560 |
| K040249 | LEONHARD LANG GMBH |
P.O. BOX 560 | STILLWATER | MN | 55082-0560 |
| K024247 | LEONHARD LANG GMBH |
P.O. BOX 560 | STILLWATER | MN | 55082-0560 |
| K030509 | LEONHARD LANG GMBH |
P.O. BOX 560 | STILLWATER | MN | 55082-0560 |
| K080106 | LEONHARD LANG GMBH |
P.O. BOX 560 | STILLWATER | MN | 55082-0560 |
| K990110 | MAERSK MEDICAL A/S |
6401 MEADOWS WEST | FORT WORTH | TX | 76132 |
| K990112 | MAERSK MEDICAL A/S |
6401 MEADOWS WEST | FORT WORTH | TX | 76132 |
| K990113 | MAERSK MEDICAL A/S |
6401 MEADOWS WEST | FORT WORTH | TX | 76132 |
| K990111 | MAERSK MEDICAL A/S |
6401 MEADOWS WEST | FORT WORTH | TX | 76132 |
| K990115 | MAERSK MEDICAL A/S |
6401 MEADOWS WEST | FORT WORTH | TX | 76132 |
| K961288 | MARQUETTE ELECTRONICS, INC. |
100 MARQUETTE DR. | JUPITER | FL | 33468 |
| K983689 | MEDICOTEST A/S |
1900 K ST. N.W. | WASHINGTON | DC | 20006-1108 |
| K020382 | MEDICOTEST A/S |
1800 MASSCHUSETTS AVE., N.W. | WASHINGTON | DC | 20036-1221 |
| K961643 | MEDICOTEST, INC. |
ONE METROPOLITAN SQUARE | ST. LOUIS | MO | 63102 |
| K000690 | MINNESOTA MINING AND MFG. CO. |
3M CENTER | ST. PAUL | MN | 55144-1000 |
| K063044 | MONEBO TECHNOLOGIES, INC. |
1800 BARTON CREEK BLVD. | AUSTIN | TX | 78735-1606 |
| K944496 | MSB LTD. |
HILLDROP LANE, RAMSBURY | MARLBOROUGH, WILTSHIRE | SN8 2RB | |
| K944497 | MSB LTD. |
HILLDROP LANE, RAMSBURY | MARLBOROUGH, WILTSHIRE | SN8 2RB | |
| K011564 | NEOTECH PRODUCTS, INC. |
9135-F ALABAMA AVE. | CHATSWORTH | CA | 91311 |
| K972001 | NI MEDICAL |
1601 TRAPELO RD. | WALTHAM | MA | 02154 |
| K003804 | NIKO MEDICAL PRODUCTS |
6401 MEADOWS WEST | FORT WORTH | TX | 76132 |
| K022909 | NIKOMED U.S.A., INC. |
P.O. BOX 560 | STILLWATER | MN | 55082 |
| K171244 | NimbleHeart, Inc. |
1300 White Oaks Rd., Suite #201 | Campbell | CA | 95008 |
| K062760 | ORBITAL RESEARCH INC. |
4415 EUCLID AVE. | CLEVELAND | OH | 44103-3733 |
| K960721 | PACEART, INC. |
22 RIVERVIEW DR. | WAYNE | NJ | 07470 |
| K092744 | R & D MEDICAL PRODUCTS, INC. |
20492 CRESCENT BAY DR. #106 | LAKE FOREST | CA | 92630 |
| K962122 | SENTRY MEDICAL PRODUCTS, INC. |
331 S. EISENHOWER LN. | LOMBARD | IL | 60148 |
| K041954 | SHANGHAI INTCO ELECTRODE MANUFACTURING CO., LTD. |
500 AIRPORT WAY | SANDPOINT | ID | 83864 |
| K093327 | SHANGHAI INTCO ELECTRODE MANUFACTURING CO., LTD. |
814 AIRPORT WAY | SANDPOINT | ID | 83864 |
| K092389 | SUZUKEN CO., LTD. |
3F, 2-17-6 AKEBONO-CHO | TACHIKAWA-SHI, TOKYO | 190-0012 | |
| K982470 | TAPUZ MEDICAL TECHNOLOGY LTD. |
117 AHUZAH ST. | RA'ANANNA | 43373 | |
| K101576 | TEAM INNOVATIONS, INC |
2521 SOUTH 98 STREET | WEST ALLIS | WI | 53227 |
| K071576 | TEXTRONICS, INC |
1835 MARKET STREET | PHILADEPHIA | PA | 19103 |
| K090180 | VERMED, INC. |
9 LOVELL DR. | BELLOWS FALLS | VT | 05101 |
| K030073 | VERMONT MEDICAL, INC. |
INDUSTRIAL PARK | BELLOWS FALLS | VT | 05101 |
| K963975 | VERSATEC, INC. |
764 DENISON CT. | BLOOMFIELD HILLS | MI | 48302 |
| K970755 | VITAL CONNECTIONS, INC. |
955 NORTH THIRD ST. | TIPP CITY | OH | 45371 |
| K993934 | VQ CORP. |
3130 HIGHLAND AVE. | CINCINNATI | OH | 45219-2374 |
| K031174 | WANDY RUBBER INDUSTRIAL CO., LTD |
NO.24, ALLEY 37, LANE 392 | SHI-CHIH | 221 | |
| K123658 | ZEPHYR TECHNOLOGY CORPORATION |
1151 HOPE STREET | STAMFORD | CT | 06907 |
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