Clearance Summary
MICROSHEV MODEL 2000 received FDA 510(k) clearance under submission number K874193, sponsored by Micro-Shev , 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 1988-03-21.
- Submission: K874193
- Applicant / Sponsor: Micro-Shev , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1900
- Decision date: 1988-03-21
Classification & Regulation
This clearance is catalogued under FDA product code GWJ and 21 CFR 882.1900, within the Neurology review panel as a Class II device.