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

AID, CARDIOPULMONARY RESUSCITATION

K Number: K930429 · Decision Mar 11, 1993
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
208
Applicant Total
27
Review Days
44

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Basic Information

Device Name
AID, CARDIOPULMONARY RESUSCITATION
K Number
K930429
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.5915
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Valley Forge Scientific Corp.
Date Received
January 26, 1993
Decision Date
March 11, 1993
Product Code
BTM
Advisory Committee
Anesthesiology
Review Advisory Committee
AN
Third Party
N

Classifications

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

Product Code Device Name
BTM Ventilator, Emergency, Manual (Resuscitator)

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