Clearance Summary
NORODYN 8000 SEMG SYSTEM, ND-8000 received FDA 510(k) clearance under submission number K992439, 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 1999-08-13.
- Submission: K992439
- Applicant / Sponsor: Myotronics-Noromed, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5050
- Decision date: 1999-08-13
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.