BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Ergoline Prestige 1600 Hybrid Performance

    K Number: K180555 · Decision Oct 11, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    80
    Applicant Total
    2
    Review Days
    224

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    Basic Information

    Device Name
    Ergoline Prestige 1600 Hybrid Performance
    K Number
    K180555
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4635
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jk Holding GmbH
    Date Received
    March 1, 2018
    Decision Date
    October 11, 2018
    Product Code
    LEJ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    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 Jk Holding GmbH

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