Clearance Summary
MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY received FDA 510(k) clearance under submission number K001013, sponsored by Airsep 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 2000-05-16.
- Submission: K001013
- Applicant / Sponsor: Airsep Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2000-05-16
Classification & Regulation
This clearance is catalogued under FDA product code OLV and 21 CFR 882.1400, within the Neurology review panel as a Class II device.