The following data is part of a premarket notification filed by Ceribell, Inc. with the FDA for Ceribell Pocket Eeg Device.
| Device ID | K191301 |
| 510k Number | K191301 |
| Device Name: | Ceribell Pocket EEG Device |
| Classification | Automatic Event Detection Software For Full-montage 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 | OMB |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | OMC |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-14 |
| Decision Date | 2019-09-11 |
| Summary: | summary |