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

UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT

K Number: K953787 · Decision Sep 19, 1995
Classifications
1
FEI Numbers
199
Registration Numbers
199
Same Product Code
183
Applicant Total
5
Review Days
36

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Basic Information

Device Name
UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT
K Number
K953787
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
868.5240
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Unicor, Inc.
Date Received
August 14, 1995
Decision Date
September 19, 1995
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 Unicor, Inc.

K Number Device Name
K953784 UNICOR, INC. CORRUGATED TUBING
K953786 UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS
K953788 UNICOR, INC. GAS SAMPLING LINES & CONNECTORS
K953785 UNICOR, INC. VENTILATOR HOSES