The following data is part of a premarket notification filed by Ceribell, Inc. with the FDA for Ceribell Instant Eeg Headband.
| Device ID | K171459 |
| 510k Number | K171459 |
| Device Name: | Ceribell Instant EEG Headband |
| Classification | Electrode, Cutaneous |
| Applicant | Ceribell, Inc. 2483 Old Middlefield Way, Suite 120 Mountain View, CA 94043 |
| Contact | Josef Parvizi |
| Correspondent | Josef Parvizi Ceribell, Inc. 2483 Old Middlefield Way, Suite 120 Mountain View, CA 94043 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-18 |
| Decision Date | 2017-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851420007038 | K171459 | 000 |
| 00851420007021 | K171459 | 000 |