FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

BABY POD

K Number: K030283 · Decision Apr 22, 2003
Classifications
1
FEI Numbers
124
Registration Numbers
124
Same Product Code
38
Applicant Total
4
Review Days
85

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Basic Information

Device Name
BABY POD
K Number
K030283
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
880.6900
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Prism Enterprises, Inc.
Date Received
January 27, 2003
Decision Date
April 22, 2003
Product Code
FPP
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
FPP Stretcher, Hand-Carried

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K Number Device Name
K020447 MITYVAC MERLIN, MODEL 10027
K011532 MITYVAC
K000444 MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM