Clearance Summary
MODEL MES-9000/EMG SYSTEM received FDA 510(k) clearance under submission number K013399, sponsored by Myotronics-Noromed, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2001-11-13.
- Submission: K013399
- Applicant / Sponsor: Myotronics-Noromed, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5050
- Decision date: 2001-11-13
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.