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

ANESTHESIA BREATHING CIRCUIT

K Number: K851193 · Decision Jun 14, 1985
Classifications
1
FEI Numbers
199
Registration Numbers
199
Same Product Code
183
Applicant Total
5
Review Days
80

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Basic Information

Device Name
ANESTHESIA BREATHING CIRCUIT
K Number
K851193
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
868.5240
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Avatron, Inc.
Date Received
March 26, 1985
Decision Date
June 14, 1985
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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Other Clearances by Avatron, Inc.

K Number Device Name
K844956 AVA-MIST PORTABLE AIR COMPRESSOR
K843102 AVA-NEB NEBULIZER
K842778 AVATRON UNIVERSAL ADULT VOL. VENTILATOR
K842389 AVATRON DISPOSABLE I.P.P.B. CIRUCIT