510(k) K883463
K883463 is an FDA 510(k) premarket notification submitted by Commercial Products & Engineering Co. for the device "HOSPITAL BED CLOTHING CRADLE". The FDA issued a decision of Substantially Equivalent on September 19, 1988. The device falls under product code FNL (Bed, Ac-Powered Adjustable Hospital), a Class II device regulated under 21 CFR 880.5100. Commercial Products & Engineering Co. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 19, 1988
- Date Received
- August 15, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bed, Ac-Powered Adjustable Hospital
- Device Class
- Class II
- Regulation Number
- 880.5100
- Review Panel
- HO
- Submission Type