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 |
| K243339 |
IDMED |
3 rue John Maynard Keynes
| 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 |
| K242525 |
Nerbio Medical Software Platforms, Inc. |
1900 Camden Ave
| San Jose |
CA |
955124 |
| 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 |
|
|