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

CIRCUIT, INTENSIVE CARE VENTILATOR

K Number: K760352 · Decision Aug 11, 1976
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
154
Applicant Total
33
Review Days
9

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Basic Information

Device Name
CIRCUIT, INTENSIVE CARE VENTILATOR
K Number
K760352
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.5140
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Monaghan Medical Corp.
Date Received
August 2, 1976
Decision Date
August 11, 1976
Product Code
CAZ
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
CAZ Anesthesia Conduction Kit

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K123945 STRIVE DUAL ZONE PEAK FLOW METER
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K023097 TRUEZONE PEAK FLOW METER
K012939 AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER
K991212 MODIFICATION TO TRUZONE PEAK FLOW METER
K964130 AEROGEAR ASTHMA ACTION KIT
K963089 TRUZONE PEAK FLOW METER
K963095 TRUPEAK PEAK FLOW METER
K955234 TRUPEAK PEAK FLOW METER
K955262 TRUZONE PEAK FLOW METER
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