FDA 510(k) Applications for Medical Device:
Stimulator, Nerve, Peripheral, Electric
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K192958 | Blink Device Company |
1530 Westlake Ave N Suite 600 | Seattle | WA | 98109 |
| K172843 | Blink Device Corporation |
1530 Westlake Ave N Suite 600 | Seattle | WA | 98109 |
| K955026 | DATEX MEDICAL INSTRUMENTATION, INC. |
2 HIGHWOOD DR. | TEWKSBURY | MA | 01876 |
| K042003 | Draeger Medical Systems, Inc. |
16 ELECTRONICS AVE. | DANVERS | MA | 01923 |
| K953205 | FISHER & PAYKEL HEALTHCARE, LTD. |
25 CARBINE ROAD PANMURE | AUCKLAND, NEW ZEALAND | ||
| K051635 | GE HEALTHCARE |
86 PILGRIM ROAD | NEEDHAM | MA | 02492 |
| K162048 | HALYARD HEALTH - IRVINE |
43 DISCOVERY, SUITE 100 | IRVINE | CA | 92618 |
| K023342 | HDC CORP. |
628 GIBRALTAR COURT | MILPITAS | CA | 95035 |
| K172690 | Idmed |
Hotel Technoptic - 2 rue Marc Donadille | Marseille | 13013 | |
| K954505 | LIFE-TECH INTL., INC. |
10920 KINGHURST | HOUSTON | TX | 77099 |
| K955031 | LIFE-TECH INTL., INC. |
P.O. BOX 36221 | HOUSTON | TX | 77236-6221 |
| K212434 | MIPM Mammendorfer Institut fⁿr Physik und Medizin GmbH |
Oskar-von-Miller Str. 6 | Mammendorf | 82291 | |
| K002889 | NEOTONUS, INC. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K220976 | Nihon Kohden Corporation |
1-31-4 Nishiochiai, Shinjuki-Ku | Tokyo | 161-8560 | |
| K213316 | Nihon Kohden Corporation |
1-31-4 Nishiochiai, Shinjuki-Ku | Tokyo | 161-8560 | |
| K201949 | Nihon Kohden Corporation |
1-31-4 Nishiochiai, Shinjuki-Ku | Tokyo | 161-8560 | |
| K972698 | ORGANON TEKNIKA CORP. |
100 AKZO AVE. | DURHAM | NC | 27712 |
| K992596 | ORGANON TEKNIKA CORP. |
100 AKZO AVE. | DURHAM | NC | 27712 |
| K992598 | ORGANON TEKNIKA CORP. |
100 AKZO AVE. | DURHAM | NC | 27712 |
| K190795 | Senzime AB |
Ulls vag 29B | Uppsala | 756 51 | |
| K220530 | Senzime AB |
Ulls vag 41 | Uppsala | 75651 |
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