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

    OSRAM UVA LAMP

    K Number: K812853 · Decision Dec 9, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    57

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    Basic Information

    Device Name
    OSRAM UVA LAMP
    K Number
    K812853
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Osram GmbH
    Date Received
    October 13, 1981
    Decision Date
    December 9, 1981
    Product Code
    IOB
    Advisory Committee
    Physical Medicine
    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
    IOB Lamp, Infrared, Non Heating

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    Other Clearances by Osram GmbH

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    K863937 OSRAM ULTRAMED 400 W