Clearance Summary
J4 MYO-MONITOR received FDA 510(k) clearance under submission number K842223, sponsored by Myo-Tronics Research, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1984-11-19.
- Submission: K842223
- Applicant / Sponsor: Myo-Tronics Research, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 1984-11-19
Classification & Regulation
This clearance is catalogued under FDA product code NUW and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.