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

    AIR CARE AIR SANITIZER

    K Number: K860132 · Decision Jan 13, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    35
    Applicant Total
    8
    Review Days
    364

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    Basic Information

    Device Name
    AIR CARE AIR SANITIZER
    K Number
    K860132
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6500
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Cooper-Hewitt Electric Co.
    Date Received
    January 14, 1986
    Decision Date
    January 13, 1987
    Product Code
    FRA
    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
    FRA Purifier, Air, Ultraviolet, Medical

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    Other Clearances by Cooper-Hewitt Electric Co.

    K Number Device Name
    K862608 SPERTILITE PHOTOTHERAPY LAMP
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    K813045 AQUANOMICS, #SP36SF
    K813046 AQUANOMICS, #HHU60
    K813049 AQUANOMICS, #HHU100
    K813048 AQUANOMICS, #MP2SF
    K813050 AQUANOMICS, #MP4SF