Clearance Summary
MICRO MED INT'L MICRO SOUND US-100 received FDA 510(k) clearance under submission number K812752, sponsored by N-Tron Electronics. 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 1982-01-19.
- Submission: K812752
- Applicant / Sponsor: N-Tron Electronics
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5300
- Decision date: 1982-01-19
Classification & Regulation
This clearance is catalogued under FDA product code IMI and 21 CFR 890.5300, within the Physical Medicine review panel as a Class II device.