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 |