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 |
| K243185 | Epitel |
465 S 400 E | Salt Lake City | UT | 84111 |
| K203827 | Epitel, Inc. |
124 S. 400 E. | Salt Lake City | UT | 84111 |
| K230933 | Epitel, Inc. |
465 South 400 East | Salt Lake City | UT | 84111 |
| K242306 | Forest Devices, Inc. |
544 Miltenberger St | Pittsburgh | PA | 15219 |
| K131944 | JORDAN NEUROSCIENCE, INC. |
1660 PLUM LANE | REDLANDS | CA | 92374 |
| K024245 | MENNEN MEDICAL LTD. |
4 HAYARDEN ST., YAVNE | REHOVOT | 76100 | |
| K242930 | Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) |
2568 Bristol Circle | Oakville | L6H 5S1 | |
| 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 |
| K232779 | QX World Ltd |
Tinodi utca 1-3 A.ep, IV.em, 93 | Budapest | 1095 |
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