Clearance Summary
ADVANTAGE EMG SYSTEM, MODEL #A100 received FDA 510(k) clearance under submission number K974010, sponsored by Advantage Medical Division of Cme Telemetrix. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1998-01-16.
- Submission: K974010
- Applicant / Sponsor: Advantage Medical Division of Cme Telemetrix
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.1375
- Decision date: 1998-01-16
Classification & Regulation
This clearance is catalogued under FDA product code IKN and 21 CFR 890.1375, within the Physical Medicine review panel as a Class II device.