Clearance Summary
PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE received FDA 510(k) clearance under submission number K132306, sponsored by Persyst Development Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2013-11-21.
- Submission: K132306
- Applicant / Sponsor: Persyst Development Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2013-11-21
Classification & Regulation
This clearance is catalogued under FDA product code OMB and 21 CFR 882.1400, within the Neurology review panel as a Class II device.