FDA 510(k) Applications for Medical Device:
Reduced- Montage Standard Electroencephalograph
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K130013 |
ADVANCED BRAIN MONITORING INC. |
W324 S3649 COUNTY ROAD E
| DOUSMAN |
WI |
53118 |
K120447 |
ADVANCED BRAIN MONITORING, INC. |
W324 S3649 COUNTY RD E
| DOUSMAN |
WI |
53118 |
K152040 |
ADVANCED BRAIN MONITORING, INC. |
2237 FARADAY AVENUE, SUITE 100
| CARLSBAD |
CA |
92008 |
K192549 |
Byteflies NV |
Borsbeeksebrug 22 Floor 6
| Antwerp |
|
B-2600 |
K170363 |
Ceribell, Inc. |
2483 Old Middlefield Way, Suite 120
| Mountain View |
CA |
94043 |
K013863 |
CLEVELAND MEDICAL DEVICES, INC. |
11000 CEDAR AVE., SUITE 130
| CLEVELAND |
OH |
44106 |
K970672 |
CLEVELAND MEDICAL DEVICES, INC. |
11000 CEDAR AVE.
| CLEVELAND |
OH |
44106 |
K001110 |
CLEVELAND MEDICAL DEVICES, INC. |
11000 CEDAR AVE., SUITE 130
| CLEVELAND |
OH |
44106 |
K060523 |
CYBERKINETICS, INC. |
800 LEVANGER LANE
| STOUGHTON |
WI |
53589 |
K203827 |
Epitel, Inc. |
124 S. 400 E.
| Salt Lake City |
UT |
84111 |
K230933 |
Epitel, Inc. |
465 South 400 East
| Salt Lake City |
UT |
84111 |
K131944 |
JORDAN NEUROSCIENCE, INC. |
1660 PLUM LANE
| REDLANDS |
CA |
92374 |
K024245 |
MENNEN MEDICAL LTD. |
4 HAYARDEN ST., YAVNE
| REHOVOT |
|
76100 |
K223628 |
Neba Health, LLC |
2052 Gordon Highway, Ste B.
| Augusta |
GA |
30909 |
K110967 |
NEURALYNX INC |
105 COMMERCIAL DRIVE
| BOZEMAN |
MT |
59715-2217 |
K221563 |
Neurosteer Inc. |
375 South End Avenue Suite 26C
| New York |
NY |
10280 |
K092477 |
NEUROWAVE SYSTEMS, INC. |
2490 LEE BLVD.
| CLEVELAND HEIGHTS |
OH |
44118 |
K183529 |
Nihon Kohden Corporation |
1-31-4 Nishiochiai, Shinjuku-ku
| Tokyo |
|
161-8560 |
K020335 |
OLYMPIC MEDICAL CORP. |
5900 FIRST AVE., SOUTH
| SEATTLE |
WA |
98108 |
K021485 |
OXFORD BIOSIGNALS LIMITED |
1468 HARWELL AVE.
| CROFTON |
MD |
21114-4341 |
K042309 |
OXFORD BIOSIGNALS LIMITED |
611 RIGGIN ROAD
| TROY |
IL |
62294 |
|
|