FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

PEDICRAFT BED, MODEL B2944

K Number: K821773 · Decision Jun 23, 1982
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
26
Applicant Total
5
Review Days
7

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Basic Information

Device Name
PEDICRAFT BED, MODEL B2944
K Number
K821773
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5140
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Pedicraft, Inc.
Date Received
June 16, 1982
Decision Date
June 23, 1982
Product Code
FMS
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
FMS Bed, Pediatric Open Hospital

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Other Clearances by Pedicraft, Inc.

K Number Device Name
K925949 PEDICRAGT BASSINET
K925817 HEAD & FOOT END DROP PEDI-CRIB
K905630 INFANT REFLUX SLING
K905629 PEDICRAFT INFANT REFLUX WEDGE