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

    BARRIERFLEX-PF PULMONARY FUNCTION TESTING FILTER

    K Number: K934540 · Decision Oct 19, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    201
    Applicant Total
    7
    Review Days
    33

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    Basic Information

    Device Name
    BARRIERFLEX-PF PULMONARY FUNCTION TESTING FILTER
    K Number
    K934540
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5260
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bird Life Design
    Date Received
    September 16, 1993
    Decision Date
    October 19, 1993
    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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