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

    AMERICAN TWA WAY FILTER -BACTERIAL/VIRAL-RETENTIVE

    K Number: K850265 · Decision Apr 5, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    201
    Applicant Total
    64
    Review Days
    72

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    Basic Information

    Device Name
    AMERICAN TWA WAY FILTER -BACTERIAL/VIRAL-RETENTIVE
    K Number
    K850265
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5260
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    American Pharmaseal Div. Ahsc
    Date Received
    January 23, 1985
    Decision Date
    April 5, 1985
    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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