Clearance Summary
MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE received FDA 510(k) clearance under submission number K970051, sponsored by Smith and Nephew Donjoy, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1997-07-10.
- Submission: K970051
- Applicant / Sponsor: Smith and Nephew Donjoy, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5050
- Decision date: 1997-07-10
Classification & Regulation
This clearance is catalogued under FDA product code HCC and 21 CFR 882.5050, within the Neurology review panel as a Class II device.