510(k) K845003

CUDDLE CARRIER - INFANT BED by International Purchasing Services — Product Code FMS

K845003 is an FDA 510(k) premarket notification submitted by International Purchasing Services for the device "CUDDLE CARRIER - INFANT BED". The FDA issued a decision of Substantially Equivalent on April 23, 1986. The device falls under product code FMS (Bed, Pediatric Open Hospital), a Class II device regulated under 21 CFR 880.5140. International Purchasing Services has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1986
Date Received
December 26, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Pediatric Open Hospital
Device Class
Class II
Regulation Number
880.5140
Review Panel
HO
Submission Type