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

    DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER

    K Number: K970659 · Decision May 16, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    19
    Applicant Total
    14
    Review Days
    84

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    Basic Information

    Device Name
    DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER
    K Number
    K970659
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1855
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Telediagnostic Systems, Inc.
    Date Received
    February 21, 1997
    Decision Date
    May 16, 1997
    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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