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

MEDIRESP III

K Number: K924272 · Decision Feb 9, 1994
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
99
Applicant Total
1
Review Days
534

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Basic Information

Device Name
MEDIRESP III
K Number
K924272
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.5925
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Medflow Corp., Inc.
Date Received
August 24, 1992
Decision Date
February 9, 1994
Product Code
BTL
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
BTL Ventilator, Emergency, Powered (Resuscitator)

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