Clearance Summary
MODEL 4000 EVOKED POTENTIAL MEASUREMENT SYSTEM received FDA 510(k) clearance under submission number K894608, 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 1989-12-29.
- Submission: K894608
- Applicant / Sponsor: Micro-Shev , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1870
- Decision date: 1989-12-29
Classification & Regulation
This clearance is catalogued under FDA product code GWF and 21 CFR 882.1870, within the Neurology review panel as a Class II device.