Clearance Summary
MEGA ME 3000 PROFESSIONAL MUSCLE TESTER received FDA 510(k) clearance under submission number K963202, sponsored by Mega Electronics , 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 1997-05-19.
- Submission: K963202
- Applicant / Sponsor: Mega Electronics , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5050
- Decision date: 1997-05-19
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.