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

    HYGIENIC AIR PURIFYING DEVICE

    K Number: K861299 · Decision Jul 23, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    51
    Applicant Total
    1
    Review Days
    107

    Basic Information

    Device Name
    HYGIENIC AIR PURIFYING DEVICE
    K Number
    K861299
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5045
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    PURIDYNE, INC./IMUTECH, INC.
    Date Received
    April 7, 1986
    Decision Date
    July 23, 1986
    Product Code
    FRF
    Advisory Committee
    General Hospital
    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
    FRF Cleaner, Air, Medical Recirculating

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