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

    BREATHING CIRCUIT BACTERIAL FILTERS

    K Number: K892520 · Decision Aug 2, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    201
    Applicant Total
    15
    Review Days
    113

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    Basic Information

    Device Name
    BREATHING CIRCUIT BACTERIAL FILTERS
    K Number
    K892520
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5260
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Arbo Medical, Inc.
    Date Received
    April 11, 1989
    Decision Date
    August 2, 1989
    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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