Clearance Summary
SPEMBLY 9000 & 9300 received FDA 510(k) clearance under submission number K802063, 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 1980-10-03.
- Submission: K802063
- Applicant / Sponsor: Spembly Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 1980-10-03
Classification & Regulation
This clearance is catalogued under FDA product code GZJ and 21 CFR 882.5890, within the Neurology review panel as a Class II device.