FDA 510(k) Applications for Medical Device:
Electrocardiograph,Ambulatory(Without Analysis)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K222017 | Biotricity |
203 Redwood Shores Pkwy | Redwood City | CA | 94065 |
| K211709 | Biotricity |
275 Shoreline Drive, Suite 150 | Redwood City | CA | 94065 |
| K993617 | BRAEMAR CORP. |
11481 RUPP DR. | BURNSVILLE | MN | 55337 |
| K993618 | BRAEMAR CORP. |
11481 RUPP DR. | BURNSVILLE | MN | 55337 |
| K030856 | BRAEMAR CORP. |
11481 RUPP DR. | BURNSVILLE | MN | 55337 |
| K130294 | BRAEMAR MANUFACTURING LLC |
750 B. STREET, STUITE 1400 | SAN DIEGO | CA | 92101 |
| K042469 | BRAEMAR, INC. |
11481 RUPP DR. | BURNSVILLE | MN | 55337 |
| K071733 | BRAEMAR, INC. |
1285 CORPORATE CENTER DR. | EAGAN | MN | 55121 |
| K071011 | BRAEMAR, INC. |
1285 CORPORATE CENTER DR. | EAGAN | MN | 55121 |
| K100310 | BTL INDUSTRIES, INC |
1705 S. CAPITAL OF TEXAS HWY | AUSTIN | TX | 78746 |
| K100266 | CAMNTECH, LTD |
UPPER PENDRILL COURT | PAPWORTH EVERARD, CAMBRIDGESHI | CB233UY | |
| K000609 | CARDIAC TELECOMMUNICATIONS |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071-3404 |
| K003707 | CARDIONET |
6199 CORNERSTONE CT. | SAN DIEGO | CA | 92121 |
| K031074 | DATRIX |
340 STATE PLACE | ESCONDIDO | CA | 92029 |
| K982975 | DATRIX |
316 STATE PLACE | ESCONDIDO | CA | 92029 |
| K001317 | DEL MAR MEDICAL SYSTEMS, LLC. |
1621 ALTON PKWY. | IRVINE | CA | 92606 |
| K062959 | DIAGNOSTIC MONITORING SOFTWARE |
292 KINGSBURY GRADE, #32 | STATELINE | NV | 89449 |
| K133014 | DIAGNOSTIC MONITORING SOFTWARE |
290 Kingsbury Grade # 3 | Stateline | NV | 89449 |
| K032466 | ELA MEDICAL, INC. |
2950 XENIUM LN. NORTH, #120 | PLYMOUTH | MN | 55441 |
| K091054 | ET MEDICAL DEVICES SPA |
6, VIA DE ZINIS | CAVARENO(TN) | 38011 | |
| K101969 | EXELYS LLC |
1705 S. CAPITAL OF TEXAS HWY | AUSTIN | TX | 78746 |
| K050731 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
8200 WEST TOWER AVE. | MILWAUKEE | WI | 53223 |
| K021470 | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
8200 WEST TOWER AVE. | MILWAUKEE | WI | 53223 |
| K122272 | GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG |
55 Northern Blvd | Great Neck | NY | 11021 |
| K051686 | GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG |
55 Northern Blvd | Great Neck | NY | 11021 |
| K063042 | GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG |
55 Northern Blvd | Great Neck | NY | 11021 |
| K130785 | GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG |
ODERSTRASSE 77 | TELTOW | 14513 | |
| K231424 | HeartBeam, Inc. |
2118 Walsh Avenue | Santa Clara | CA | 95110 |
| K982617 | HEARTLAND MEDICAL SYSTEMS, INC. |
725 PICKFORD CT. | NEWBURY PARK | CA | 91320 |
| K982843 | INDUSTRIAL TECHNOLOGY RESEARCH INSTITUTE |
BLDG 16, 321 KUANG FU RD,SEC 2 | HSINCHU | ||
| K073545 | INOVISE MEDICAL, INC. |
10565 SW NIMBUS AVE. | PORTLAND | OR | 97223 |
| K001349 | INOVISE MEDICAL, INC. |
1025 INDUSTRIAL PKWY. | NEWBERG | OR | 97132 |
| K112601 | INTRICON DATRIX CORPORATION |
962 ALLEGRO LANE | APOLLO BEACH | FL | 33572 |
| K233864 | Kestra Medical Technologies, Inc. |
3933 Lake Washington Boulevard NE | Kirkland | WA | 98033 |
| K210758 | Medicalgorithmics S.A. |
Aleje Jerozolimskie 81 | Warsaw | 02-001 | |
| K102723 | MEMTEC CORP. |
68 STILES RD. UNIT D | SALEM | NH | 03079 |
| K071085 | MICRO-STAR INTERNATIONAL CO., LTD. |
NO. 69, LI-DE STREET | JUNG-HE CITY, TAIPEI HSIEN | 235 | |
| K152626 | MORTARA INSTRUMENT, INC |
7865 NORTH 86TH ST. | MILWAUKEE | WI | 53224 |
| K021373 | MORTARA INSTRUMENT, INC. |
7865 NORTH 86TH ST. | MILWAUKEE | WI | 53224 |
| K043010 | MORTARA INSTRUMENT, INC. |
7865 NORTH 86TH ST. | MILWAUKEE | WI | 53224 |
| K003520 | NEXAN LTD |
1801 ROCKVILLE PIKE | ROCKVILLE | MD | 20852 |
| K993643 | NEXAN TELEMED LTD. |
15825 SHADY GROVE RD. | ROCKVILLE | MD | 20850-4008 |
| K992584 | NHE CORP. |
7100 FERNWOOD AVE. | RICHMOND | VA | 23228 |
| K161062 | Norav Medical GmbH |
Otto von Guericke Ring 10 | Wiesbaden | 65205 | |
| K142424 | NORTH EAST MONITORING INC. |
2 CLOCK TOWER PLACE, STE 555 | MAYNARD | MA | 01754 |
| K070014 | NORTHEAST MONITORING, INC. |
543 LONG HILL AVENUE | SHELTON | CT | 06484 |
| K001288 | NORTHEAST MONITORING, INC. |
730 BOSTON POST RD. | SUDBURY | MA | 01776 |
| K041901 | NORTHEAST MONITORING, INC. |
543 LONG HILL AVENUE | SHELTON | CT | 06484 |
| K061293 | NORTHEAST MONITORING, INC. |
543 LONG HILL AVENUE | SHELTON | CT | 06484 |
| K112573 | PLATINUM TEAM CO., LTD |
396 DAYE ROAD | TAIPAI | 11268 | |
| K032882 | RECOM MANAGED SYSTEMS, INC. |
4705 LAUREL CANYON BLVD. | VALLEY VILLAGE | CA | 91607 |
| K032276 | REMCO ITALIA S.P.A. |
VIA RIVOLTANA NUOVA 53 | SOUTH PEDRINO DI VIGNATE, MI. | 20060 | |
| K011837 | REYNOLDS MEDICAL LTD. |
377 RT. 17 S. | HASBROUCK HEIGHTS | NJ | 07604 |
| K083382 | SCOTTCARE CORPORATION |
4791 WEST 150TH ST. | CLEVELAND | OH | 44135 |
| K173156 | Sensydia, Inc. |
907 Westwood Boulevard, Suite 358 | Los Angeles | CA | 90024 |
| K212317 | Spacelabs Healthcare Ltd. |
Unit B, Foxholes Centre, John Tate Road | Hertford | SG13 7DT | |
| K211651 | Spacelabs Healthcare Ltd. |
Unit B, Foxholes Centre, John Tate Road | Hertford | SG13 7DT | |
| K101024 | SUZUKEN CO., LTD. |
1201 RICHARDSON | RICHARDSON | TX | 75080 |
| K992425 | TES ELECTRICAL ELECTRONIC CORP. |
NO.57 JEN-AI ROAD SEC. 2 | TAIPEI, TAIWAN 300 | 300 |
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