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

    QUADRASORB FILTER

    K Number: K923661 · Decision Oct 20, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    201
    Applicant Total
    14
    Review Days
    90

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    Basic Information

    Device Name
    QUADRASORB FILTER
    K Number
    K923661
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5260
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Union Broach, Div. Moyco Industries, Inc.
    Date Received
    July 22, 1992
    Decision Date
    October 20, 1992
    Product Code
    CAH
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CAH Filter, Bacterial, Breathing-Circuit

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    K935542 NICKEL-TITANIUM K-TYPE FILE
    K931742 INJECT-R FILL
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    K852474 UNION BROACH BLEACHING LIGHT
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