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

    ELECTROSTATIC HYDROPHOBIC BREATHING FILTER

    K Number: K002201 · Decision Feb 5, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    201
    Applicant Total
    12
    Review Days
    200

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    Basic Information

    Device Name
    ELECTROSTATIC HYDROPHOBIC BREATHING FILTER
    K Number
    K002201
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5260
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sims Portex, Inc.
    Date Received
    July 20, 2000
    Decision Date
    February 5, 2001
    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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