Clearance Summary
DR-3, DR-6, DR-68, DR-88, AMR-6, FR-22R, DR-22B received FDA 510(k) clearance under submission number K944884, sponsored by Kolvin Industries , Ltd.. 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 1995-02-14.
- Submission: K944884
- Applicant / Sponsor: Kolvin Industries , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5660
- Decision date: 1995-02-14
Classification & Regulation
This clearance is catalogued under FDA product code ISA and 21 CFR 890.5660, within the Physical Medicine review panel as a Class I device.