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

    M5 Recorder

    K Number: K202456 · Decision Dec 29, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    193
    Applicant Total
    5
    Review Days
    124

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    Basic Information

    Device Name
    M5 Recorder
    K Number
    K202456
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Global Instrumentation, LLC
    Date Received
    August 27, 2020
    Decision Date
    December 29, 2020
    Product Code
    DSH
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    DSH Recorder, Magnetic Tape, Medical

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