FDA 510(k) Applications for Medical Device:
Electrocardiograph, Ambulatory, With Analysis Algorithm
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K003763 | AGILENT TECHNOLOGIES |
1201 "B" N. RICE AVE. | OXNARD | CA | 93030 |
| K003940 | AGILENT TECHNOLOGIES |
1201 "B" N. RICE AVE. | OXNARD | CA | 93030 |
| K010949 | AGILENT TECHNOLOGIES |
1201 "B" N. RICE AVE. | OXNARD | CA | 93030 |
| K024323 | BIOMEDICAL SYSTEMS CORP. |
2464 WEST PORT PLAZA DR. | ST. LOUIS | MO | 63146 |
| K182030 | Bittium Biosignals Ltd. |
Pioneerinkatu 6 | Kuopio | FI-70800 | |
| K031466 | BRENTWOOD MEDICAL TECHNOLOGY CORP. |
3300 FUJITA ST. | TORRANCE | CA | 90505 |
| K193177 | CardioCalm |
Corso Martiri della Liberta, nr. 40 | Montichiari | 25018 | |
| K010396 | CARDIONETICS, LTD. |
195 WEST ST. | WALTHAM, | MA | 02451 |
| K101273 | CONTEC MEDICAL SYSTEM CO., LTD. |
SUITE 5D, NO. 19, LANE 999 | SHANGHAI | 200030 | |
| K062088 | DIAGNOSTIC MONITORING SOFTWARE |
292 KINGSBURY GRADE, #32 | STATELINE | NV | 89449 |
| K092853 | GALIX BIOMEDICAL INSTRUMENTATION, INC. |
2555 COLLINS AVE., C-5 | MIAMI BEACH | FL | 33140 |
| K992706 | GALIX BIOMEDICAL INSTRUMENTATION, INC. |
2555 COLLINS AVE., C-5 | MIAMI BEACH | FL | 33140 |
| K042782 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
8200 WEST TOWER AVE. | MILWAUKEE | WI | 53223 |
| K051730 | GLOBAL INSTRUMENTATION, LLC |
8104 CAZENOVIA ROAD | MANLIUS | NY | 13104 |
| K110569 | INOVISE MEDICAL, INC. |
8770 SW NIMBUS AVENUE | BEAVERTON | OR | 97008-7196 |
| K120462 | INOVISE MEDICAL, INC. |
8770 SW NIMBUS AVE. | Beaverton | OR | 97008 |
| K130660 | INOVISE MEDICAL, INC. |
8770 SW NIMBUS AVE. | Beaverton | OR | 97008 |
| K140847 | LABTECH KFT. |
VAGU 4 | DEBRECEN | 4031 | |
| K063339 | MEDICK HEALTHCARE LTD. |
8303 N.E. JUANITA DRIVE | KIRKLAND | WA | 98034 |
| K043454 | MEDICOMP, INC. |
55 Northern Blvd. | Great Neck | NY | 11021 |
| K004017 | MORTARA INSTRUMENT, INC. |
7865 NORTH 86TH ST. | MILWAUKEE | WI | 53224 |
| K111487 | NORAV MEDICAL CORP. |
INDUSTRIAL PARK 13, | MITZPE AVIV | 20187 | |
| K012712 | NORAV MEDICAL LTD. |
12505 58TH AVE. N. | PLYMOUTH | MN | 55442 |
| K040753 | NOVACOR |
4, PASSAGE SAINT-ANTOINE | RUEIL MALMAISON CEDEX | 92508 | |
| K042108 | NOVACOR |
4, PASSAGE SAINT-ANTOINE | RUEIL MALMAISON CEDEX | 92508 | |
| K993788 | NOVACOR DIV. |
203 MAIN ST. PMB 166 | FLEMINGTON | NJ | 08822 |
| K131897 | VALES & HILLS BIOMEDICAL TECH. LTD. |
P.O. BOX 120-119 | SHANGHAI | 200120 | |
| K200833 | VivaQuant Inc. |
4339 Nancy Place, Suite 100 | St. Paul | MN | 55126 |
| K990170 | ZYMED MEDICAL INSTRUMENTATION |
20 NORTH AVIADOR ST. | CAMARILLO | CA | 93010 |
| K992197 | ZYMED MEDICAL INSTRUMENTATION |
20 NORTH AVIADOR ST. | CAMARILLO | CA | 93010 |
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