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

    HEPACRON PUREAIR-ZONE SYSTEM

    K Number: K862432 · Decision Oct 16, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    51
    Applicant Total
    1
    Review Days
    112

    Basic Information

    Device Name
    HEPACRON PUREAIR-ZONE SYSTEM
    K Number
    K862432
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5045
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    HEPACRON, INC.
    Date Received
    June 26, 1986
    Decision Date
    October 16, 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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