Clearance Summary
THE BODY COOLER SYSTEM received FDA 510(k) clearance under submission number K904998, sponsored by Costa / French. 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 1991-01-14.
- Submission: K904998
- Applicant / Sponsor: Costa / French
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5720
- Decision date: 1991-01-14
Classification & Regulation
This clearance is catalogued under FDA product code ILO and 21 CFR 890.5720, within the Physical Medicine review panel as a Class II device.