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

BABY BOARDS IV SUPPORT ASSEMBLY

K Number: K900134 · Decision Jul 9, 1990
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
63
Applicant Total
1
Review Days
180

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Basic Information

Device Name
BABY BOARDS IV SUPPORT ASSEMBLY
K Number
K900134
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
880.5210
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Baby Boards, Inc.
Date Received
January 10, 1990
Decision Date
July 9, 1990
Product Code
KMK
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
KMK Device, Intravascular Catheter Securement

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