Clearance Summary
RICH-MAR MODEL 510 ULTRASOUND received FDA 510(k) clearance under submission number K915557, sponsored by Rich-Mar Corp.. 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 1992-03-10.
- Submission: K915557
- Applicant / Sponsor: Rich-Mar Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5300
- Decision date: 1992-03-10
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.