510(k) K883463

HOSPITAL BED CLOTHING CRADLE by Commercial Products & Engineering Co. — Product Code FNL

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