FDA 510(k) Applications for Medical Device:
Recorder, Magnetic Tape, Medical
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K223382 | Aevice Health Pte. Ltd. |
18 Howard Road, #06-11 Novelty Bizcentre | Singapore | 369585 | |
| K243603 | Aevice Health Pte. Ltd. |
18 Howard Road, #06-11 Novelty Bizcentre | Singapore | 369585 | |
| K971604 | ALEXANDER MFG. CO. |
1511 S GARFIELD PL | MASON CITY | IA | 50401 |
| K172862 | Andon Health Co., Ltd. |
No. 3 Jin Ping Street | Tianjin | 300190 | |
| K203638 | ATsens Co., Ltd |
Point Town 806, 11, Gumi-ro, Bundang-gu | Seongnam-si | 13637 | |
| K242583 | ATsens Co.,Ltd. |
Point Town 803, 11, Gumi-ro, Bundang-gu, | Seongnam-si | 13637 | |
| K191000 | Bardy Diagnostics, Inc |
316 Occidental Avenue South, Suite B310 | Seattle | WA | 98104 |
| K191471 | Bardy Diagnostics, Inc |
316 Occidental Avenue South, Suite B310 | Seattle | WA | 98104 |
| K192556 | Bardy Diagnostics, Inc |
316 Occidental Avenue South, Suite B310 | Seattle | WA | 98104 |
| K200870 | Bardy Diagnostics, Inc |
316 Occidental Avenue South, Suite B310 | Seattle | WA | 98104 |
| K143067 | BARDY DIAGNOSTICS, INC. |
17141 VASHON HIGHWAY, SW. | VASHON ISLAND | WA | 98070 |
| K233110 | Bardy Diagnostics, Inc. |
220 120th Avenue NE, Suite 100 | Bellevue | WA | 98005 |
| K210036 | Bardy Diagnostics, Inc. |
316 Occidental Avenue South | Seattle | WA | 98104 |
| K201040 | Biotricity |
275 Shoreline Drive, Suite 150 | Redwood City | CA | 94065 |
| K162571 | Biotricity Inc. |
75 International Blvd, Suite 300 | Toronto | M9W 6L9 | |
| K171410 | Braemar Manufacturing, LLC |
3890 Murphy Canyon Road, Suite 100 | San Diego | CA | 92123 |
| K982448 | CAPINTEC, INC. |
540 ALPHA DR. | PITTSBURGH | PA | 15238 |
| K020825 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
6779 MESA RIDGE RD. | SAN DIEGO | CA | 92121-2909 |
| K111745 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
555 ZANG STREET | LAKEWOOD | CO | 80228 |
| K130288 | CARDIAC INSIGHT, INC. |
5672 FLAGLER ROAD | NORDLAND | WA | 98358 |
| K142468 | CARDIAC INSIGHT, INC. |
2815 EASTLAKE AVE. E., STE#300 | SEATTLE | WA | 98102 |
| K162503 | Cardiac Insight, Inc. |
3230 Carillon Point | Kirkland | WA | 98033 |
| K113176 | CARDIAC SCIENCE CORPORATION |
3303 MONTE VILLA PKWY. | BOTHELL | WA | 98021 |
| K022297 | CARDIOCOMM SOLUTIONS, INC. |
3060 CEDAR HILL RD., SUITE 201 | VICTORIA, B.C. | V8T 3J5 | |
| K013354 | CARDIOCOMM SOLUTIONS, INC. |
3060 CEDAR HILL RD., SUITE 201 | VICTORIA, B.C. | V8T 3J5 | |
| K111320 | CARDIOCOMM SOLUTIONS, INC. |
962 ALLEGRO LANE | APOLLO BEACH | FL | 33572 |
| K033037 | CARDIOCOMM SOLUTIONS, INC. |
3060 CEDAR HILL RD., SUITE 201 | VICTORIA, B.C. | V8T 3J5 | |
| K963174 | DEL MAR AVIONICS |
1621 ALTON PKWY. | IRVINE | CA | 92606-4801 |
| K990027 | DEL MAR AVIONICS |
1621 ALTON PKWY. | IRVINE | CA | 92606-4801 |
| K970298 | DIAGNOSTIC MONITORING |
2101 EAST 4TH ST., BLDG. B#270 | SANTA ANA | CA | 92705 |
| K062007 | DIAGNOSTIC MONITORING SOFTWARE |
292 KINGSBURY, 32B | STATELINE | NV | 89449 |
| K163535 | DMS-SERVICE LLC |
11845 W OLYMPIC BLVD | LOS ANGELES | CA | 90064 |
| K131190 | DMS-SERVICE LLC |
2800 NEILSON WAY, STE. 1 | SANTA MONICA | CA | 90405 |
| K160704 | DMS-SERVICE LLC |
11845 W. OLYMPIC BLVD STE 880W | LOS ANGELES | CA | 90064 |
| K230184 | Edan Instruments, Inc. |
#15 Jinhui Road,Jinsha Community, | Shenzhen | 518122 | |
| K971670 | GALIX BIOMEDICAL INSTRUMENTATION, INC. |
2555 COLLINS AVE., C-5 | MIAMI BEACH | FL | 33140 |
| K202456 | Global Instrumentation LLC |
8104 Cazenovia Road | Manlius | NY | 13104 |
| K982384 | HARLEY STREET SOFTWARE LTD. |
771 VANALMAN AVE. | VICTORIA, B.C. | V87 3B8 | |
| K974420 | HEWLETT-PACKARD CO. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K223049 | Icentia Inc. |
2750 Einstein St | Quebec | G1P4R1 | |
| K202359 | iRhythm Technologies, Inc. |
699 8th Street | San Francisco | CA | 94103 |
| K113862 | IRHYTHM TECHNOLOGIES, INC. |
650 TOWNSEND STREET | SAN FRANCISCO | CA | 94103 |
| K121319 | IRHYTHM TECHNOLOGIES, INC. |
650 TOWNSEND STREET | SAN FRANCISCO | CA | 94103 |
| K090363 | IRHYTHM TECHNOLOGIES, INC. |
650 TOWNSEND STREET | SAN FRANCISCO | CA | 94103 |
| K143513 | iRhythm Technologies, Inc. |
650 Townsend Street, Ste 380 | San Francisco | CA | 94103 |
| K101022 | KARMELSONIX |
31 HAAVODA ST. | BINYAMINA | ||
| K203168 | LifeLens Technologies, Inc. |
1 Ivybrook Blvd, Suite 115 | Ivyland, Bucks | PA | 18974 |
| K944180 | MEMTEC CORP. |
19B KEEWAYDIN DR. | SALEM | NH | 03079 |
| K232670 | Mezoo Co., Ltd. |
Room 808, 200 Gieopdosi-ro Jijeong-myeon, | Wonju-si | 26354 | |
| K050896 | MORTARA INSTRUMENT, INC. |
7865 NORTH 86TH ST. | MILWAUKEE | WI | 53224 |
| K004007 | NORTHEAST MONITORING, INC. |
730 BOSTON POST RD. | SUDBURY | MA | 01776 |
| K960925 | NORTHEAST MONITORING, INC. |
730 BOSTON POST RD., SUITE 22 | SUDBURY | MA | 01776 |
| K970902 | OXFORD INSTRUMENTS MEDICAL SYSTEMS |
11526 53ND ST. N | CLEARWATER | FL | 34620 |
| K171936 | Peerbridge Health INc. |
1440 Broadway, 23rd Floor | New York | NY | 10018 |
| K032103 | PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD. | ANDOVER | MA | 01810 |
| K201644 | Qardio Inc. |
345 California Street, Suite 600 & 700 | San Francisco | CA | 94104 |
| K210179 | Quanta Computer Inc. |
No. 188, Wenhua 2nd Road, Guishan District | Taoyuan City | 33377 | |
| K001025 | REYNOLDS MEDICAL LTD. |
377 RT. 17 S. | HASBROUCK HEIGHTS | NJ | 07604 |
| K022540 | ROZINN ELECTRONICS, INC. |
71-22 MYRTLE AVE. | GLENDALE | NY | 11385 |
| K973735 | SCHILLER AMERICA, INC. |
3002 DOW AVE., #138 | TUSTIN | CA | 92780 |
| K073152 | SHENZHEN CREATIVE INDUSTRY CO., LTD |
2/F, BLOCK 3 NANYOU TIAN' | SHENZHEN,GD | 518054 | |
| K173461 | Smart Solutions Technologies SL |
Calle Toronga 21, Local 1 | Madrid | 28015 | |
| K231104 | SOMNOmedics GmbH |
Am Sonnenstuhl 63 | Randersacker | D-97236 | |
| K201077 | Strados Labs |
1315 Walnut Street, Suite 1101 | Philadelphia | PA | 19107 |
| K220893 | Strados Labs, Inc. |
1315 Walnut Street, Suite 1101 | Philadelphia | PA | 19107 |
| K070818 | TOM MEDICAL ENTWICKLUNGS GMBH |
ANZENGRUBERGASSE 8 | GRAZ | A-8010 | |
| K092785 | VASOMEDICAL, INC. |
180 LINDEN AVE. | WESTBURY | NY | 11590 |
| K083820 | VASOMEDICAL, INC. |
180 LINDEN AVE. | WESTBURY | NY | 11590 |
| K111180 | VASOMEDICAL, INC. |
180 LINDEN AVE. | WESTBURY | NY | 11590 |
| K111096 | VASOMEDICAL, INC. |
180 LINDEN AVE. | WESTBURY | NY | 11590 |
| K091505 | VIASYS HEALTHCARE GMBH |
LEIBNIZSTRASSE 7 | HOECHBERG | 97204 | |
| K110525 | VITALOGRAPH(IRELAND) LTD. |
ENNIS INDUSTRIAL ESTATE | ENNIS, CO. CLARE | EI | |
| K214073 | WearLinq, Inc. |
1819 Polk St #148 | San Francisco | CA | 94109 |
| K233906 | Wellysis Corp. |
8F, 425 Teheran-ro, Gangnam-gu | Seoul | 06159 | |
| K231289 | Wellysis Corp. |
8F, 425 Teheran-ro, Gangnam-gu | Seoul | 06159 |
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