K191301 is an FDA 510(k) clearance for the Ceribell Pocket EEG Device. This device is classified as a Automatic Event Detection Software For Full-montage Electroencephalograph (Class II - Special Controls, product code OMB).
Submitted by Ceribell, Inc. (Mountainview, US). The FDA issued a Cleared decision on September 11, 2019, 120 days after receiving the submission on May 14, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1400. Automatically Mark Or Identify Electroencephalograph Waveforms For Spikes, Electrographic Seizures, Seizure-like Events In Order To Aid In Identification Of Such Events And Help Review And Annotation Of Prolonged Eeg Traces; All Output Subject To Verification By Qualified User.
| 510(k) Number | K191301 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2019 |
| Decision Date | September 11, 2019 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | OMB - Automatic Event Detection Software For Full-montage Electroencephalograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1400 |
| Definition | Automatically Mark Or Identify Electroencephalograph Waveforms For Spikes, Electrographic Seizures, Seizure-like Events In Order To Aid In Identification Of Such Events And Help Review And Annotation Of Prolonged Eeg Traces; All Output Subject To Verification By Qualified User |