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

    RESPONSE SYSTEM, TN-3000

    K Number: K781743 · Decision Dec 1, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    52
    Applicant Total
    10
    Review Days
    42

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    Basic Information

    Device Name
    RESPONSE SYSTEM, TN-3000
    K Number
    K781743
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1835
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Tracor Instruments, Inc.
    Date Received
    October 20, 1978
    Decision Date
    December 1, 1978
    Product Code
    GWL
    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
    GWL Amplifier, Physiological Signal

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    K780749 SPEECH AUDIOMETER RA 226
    K780474 AUDIOMETER CALIBRATOR MODEL RA 310
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