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

    AQUANOMICS, #HHU100

    K Number: K813049 · Decision Dec 2, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    8
    Applicant Total
    8
    Review Days
    35

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    Basic Information

    Device Name
    AQUANOMICS, #HHU100
    K Number
    K813049
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6710
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Cooper-Hewitt Electric Co.
    Date Received
    October 28, 1981
    Decision Date
    December 2, 1981
    Product Code
    KMG
    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
    KMG Purifier, Water, Ultraviolet, Medical

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