Clearance Summary
NOVAMETRIX MODEL 200 MAGSTIM received FDA 510(k) clearance under submission number K871338, sponsored by Novametrix Medical Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1987-08-04.
- Submission: K871338
- Applicant / Sponsor: Novametrix Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1870
- Decision date: 1987-08-04
Classification & Regulation
This clearance is catalogued under FDA product code GWF and 21 CFR 882.1870, within the Neurology review panel as a Class II device.