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

    HEALTH MASK

    K Number: K070467 · Decision Apr 17, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    60

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    Basic Information

    Device Name
    HEALTH MASK
    K Number
    K070467
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Polar Wrap, LLC
    Date Received
    February 16, 2007
    Decision Date
    April 17, 2007
    Product Code
    OBN
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OBN Humidifier, Respiratory, Mask (Direct Patient Interface)