Clearance Summary
EMG OPTION FOR MICROSHEV 4000 received FDA 510(k) clearance under submission number K900378, 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 1990-04-10.
- Submission: K900378
- Applicant / Sponsor: Micro-Shev , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1550
- Decision date: 1990-04-10
Classification & Regulation
This clearance is catalogued under FDA product code JXE and 21 CFR 882.1550, within the Neurology review panel as a Class II device.