510(k) K191301
K191301 is an FDA 510(k) premarket notification submitted by Ceribell, Inc. for the device "Ceribell Pocket EEG Device". The FDA issued a decision of Substantially Equivalent on September 11, 2019. The device falls under product code OMB (Automatic Event Detection Software For Full-Montage Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Ceribell, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 2019
- Date Received
- May 14, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Automatic Event Detection Software For Full-Montage Electroencephalograph
- Device Class
- Class II
- Regulation Number
- 882.1400
- Review Panel
- NE
- Submission Type
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