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

    UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX

    K Number: K093244 · Decision Oct 19, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    157
    Applicant Total
    2
    Review Days
    369

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    Basic Information

    Device Name
    UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX
    K Number
    K093244
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Geratherm Medical AG
    Date Received
    October 15, 2009
    Decision Date
    October 19, 2010
    Product Code
    DWJ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DWJ System, Thermal Regulating

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    Other Clearances by Geratherm Medical AG

    K Number Device Name
    K093694 GERATHERM UNIQUERESC