510(k) K141883
K141883 is an FDA 510(k) premarket notification submitted by Picofemto, LLC for the device "CLINISCANSM EEG". The FDA issued a decision of Substantially Equivalent on May 15, 2015. 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. Picofemto, LLC has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 2015
- Date Received
- Jul 11, 2014
- 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
- 510(k)
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