Clearance Summary
BCS NO. 1, BODY CARE SYSTEM received FDA 510(k) clearance under submission number K881800, sponsored by M & A Vertrieb, Liske Und Methling GM. 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 1988-11-16.
- Submission: K881800
- Applicant / Sponsor: M & A Vertrieb, Liske Und Methling GM
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5740
- Decision date: 1988-11-16
Classification & Regulation
This clearance is catalogued under FDA product code IRT and 21 CFR 890.5740, within the Physical Medicine review panel as a Class II device.