Clearance Summary
DISC-O-AID received FDA 510(k) clearance under submission number K821903, sponsored by M. Dahm International Aps. 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 1982-07-20.
- Submission: K821903
- Applicant / Sponsor: M. Dahm International Aps
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5050
- Decision date: 1982-07-20
Classification & Regulation
This clearance is catalogued under FDA product code IKX and 21 CFR 890.5050, within the Physical Medicine review panel as a Class I device.