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

    DRAGER SOLA SERIES, MODELS 1000/700/500/300

    K Number: K984611 · Decision Mar 29, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    73
    Applicant Total
    8
    Review Days
    90

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    Basic Information

    Device Name
    DRAGER SOLA SERIES, MODELS 1000/700/500/300
    K Number
    K984611
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Drager Medizintechnik GmbH
    Date Received
    December 29, 1998
    Decision Date
    March 29, 1999
    Product Code
    FSY
    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
    FSY Light, Surgical, Ceiling Mounted

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    Other Clearances by Drager Medizintechnik GmbH

    K Number Device Name
    K023289 OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072
    K010793 OXYLOG 1000, MODEL 2M86840
    K012177 VENTVIEW, MODEL 8414095
    K003068 SAVINA
    K010093 NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474
    K010724 SOLA 700,SOLA 500, SOLA 300
    K003067 CALEO