Clearance Summary
MODEL K7 EVALUATION DEVICE received FDA 510(k) clearance under submission number K003287, sponsored by Myotronics-Noromed, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2000-11-06.
- Submission: K003287
- Applicant / Sponsor: Myotronics-Noromed, Inc.
- Clearance pathway: Special
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.1375
- Decision date: 2000-11-06
Classification & Regulation
This clearance is catalogued under FDA product code KZM and 21 CFR 890.1375, within the Physical Medicine review panel as a Class II device.