The following data is part of a premarket notification filed by Ceribell, Inc. with the FDA for Ceribell Pocket Eeg Device.
| Device ID | K170363 |
| 510k Number | K170363 |
| Device Name: | Ceribell Pocket EEG Device |
| Classification | Reduced- Montage Standard Electroencephalograph |
| 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 | OMC |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-06 |
| Decision Date | 2017-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851420007045 | K170363 | 000 |
| 00851420007007 | K170363 | 000 |
| 00851420007052 | K170363 | 000 |