Clearance Summary
CRYOMEDICS NEUROSTAT received FDA 510(k) clearance under submission number K831963, sponsored by Spembly Medical , 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 1983-08-12.
- Submission: K831963
- Applicant / Sponsor: Spembly Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4250
- Decision date: 1983-08-12
Classification & Regulation
This clearance is catalogued under FDA product code GXH and 21 CFR 882.4250, within the Neurology review panel as a Class II device.