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

    MRI Patient Monitor TeslaDUO

    K Number: K153739 · Decision Jun 28, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    2
    Review Days
    183

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    Basic Information

    Device Name
    MRI Patient Monitor TeslaDUO
    K Number
    K153739
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mipm Mammendorfer Institut Fur Physik Und Medizin
    Date Received
    December 28, 2015
    Decision Date
    June 28, 2016
    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 Mipm Mammendorfer Institut Fur Physik Und Medizin

    K Number Device Name
    K142032 MRI PATIENT MONITORING SYSTEM TESLA M3