Clearance Summary
HOSPITAL BED CLOTHING CRADLE received FDA 510(k) clearance under submission number K883463, sponsored by Commercial Products & Engineering Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1988-09-19.
- Submission: K883463
- Applicant / Sponsor: Commercial Products & Engineering Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5100
- Decision date: 1988-09-19
Classification & Regulation
This clearance is catalogued under FDA product code FNL and 21 CFR 880.5100, within the General Hospital review panel as a Class II device.