Clearance Summary
C-ERA-100 COMPUTERIZED ELECTRIC RESPON received FDA 510(k) clearance under submission number K792085, 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 1979-10-30.
- Submission: K792085
- Applicant / Sponsor: Micro-Shev , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1900
- Decision date: 1979-10-30
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.