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

    TESLA GUARD, MODEL EFT G04

    K Number: K071802 · Decision Nov 9, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    2
    Review Days
    130

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    Basic Information

    Device Name
    TESLA GUARD, MODEL EFT G04
    K Number
    K071802
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mammendorfer Institut Fur Physik Und Medizin GmbH
    Date Received
    July 2, 2007
    Decision Date
    November 9, 2007
    Product Code
    MWI
    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
    MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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    Other Clearances by Mammendorfer Institut Fur Physik Und Medizin GmbH

    K Number Device Name
    K062974 TESLA NIBP