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

    GRINDCARE MEASURE

    K Number: K113677 · Decision Apr 5, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    18
    Applicant Total
    2
    Review Days
    113

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    Basic Information

    Device Name
    GRINDCARE MEASURE
    K Number
    K113677
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.1375
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medotech A/S
    Date Received
    December 14, 2011
    Decision Date
    April 5, 2012
    Product Code
    KZM
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KZM Device, Muscle Monitoring

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    Other Clearances by Medotech A/S

    K Number Device Name
    K092675 GRINDCARE