Clearance Summary
SOMNITOR 32K SLEEP ACTIVITY MONITOR received FDA 510(k) clearance under submission number K965079, sponsored by Neurim Pharmaceuticals, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1997-07-10.
- Submission: K965079
- Applicant / Sponsor: Neurim Pharmaceuticals, Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5050
- Decision date: 1997-07-10
Classification & Regulation
This clearance is catalogued under FDA product code LEL and 21 CFR 882.5050, within the Neurology review panel as a Class II device.