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

    TELEMETRY SYSTEM XMT-1 & REC-1

    K Number: K792371 · Decision Jan 31, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    19
    Applicant Total
    38
    Review Days
    66

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    Basic Information

    Device Name
    TELEMETRY SYSTEM XMT-1 & REC-1
    K Number
    K792371
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1855
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Burdick Corp.
    Date Received
    November 26, 1979
    Decision Date
    January 31, 1980
    Product Code
    GYE
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GYE Encephalogram Telemetry System

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