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

    SUNBED/SUNROOF OR SUNCOUCH/SUNSKY

    K Number: K801542 · Decision Aug 20, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    80
    Applicant Total
    3
    Review Days
    44

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    Basic Information

    Device Name
    SUNBED/SUNROOF OR SUNCOUCH/SUNSKY
    K Number
    K801542
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4635
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Sunfit, Inc.
    Date Received
    July 7, 1980
    Decision Date
    August 20, 1980
    Product Code
    LEJ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LEJ Booth, Sun Tan

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    Other Clearances by Sunfit, Inc.

    K Number Device Name
    K864485 SUNFIT SUNLAMP
    K861533 SUNFIT, ULTRA VIOLET LAMPS AND SUNLAMP PRODUCTS