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

    ALDAHOL III HIGH-LEVEL DISINFECTANT

    K Number: K041360 · Decision May 5, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    63
    Applicant Total
    2
    Review Days
    349

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    Basic Information

    Device Name
    ALDAHOL III HIGH-LEVEL DISINFECTANT
    K Number
    K041360
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6885
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Healthpoint, Ltd.
    Date Received
    May 21, 2004
    Decision Date
    May 5, 2005
    Product Code
    MED
    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
    MED Sterilant, Medical Devices

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    Other Clearances by Healthpoint, Ltd.

    K Number Device Name
    K091890 EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT