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

DISPOSABLE NON-REBREATHING ANES. CIRCUIT

K Number: K823714 · Decision Jan 7, 1983
Classifications
1
FEI Numbers
199
Registration Numbers
199
Same Product Code
183
Applicant Total
32
Review Days
28

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Basic Information

Device Name
DISPOSABLE NON-REBREATHING ANES. CIRCUIT
K Number
K823714
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
868.5240
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Marquest Medical Products, Inc.
Date Received
December 10, 1982
Decision Date
January 7, 1983
Product Code
CAI
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
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)

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K960972 DISPOSABLE GAS SAMPLING INTERFACE KITS
K961838 RESPIRGARD II, SPIROGARD
K904690 TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM
K903138 MARQUEST SCT 3000, HEATED HUMIDIFICATION SYSTEM
K902632 GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS
K903307 TEMP MARQ TEMPERATURE TREND INDICATOR
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