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

    GSR, 126, EEG 130-TEMP. 132, EMG 133

    K Number: K841895 · Decision Jul 17, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    171
    Applicant Total
    6
    Review Days
    71

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    Basic Information

    Device Name
    GSR, 126, EEG 130-TEMP. 132, EMG 133
    K Number
    K841895
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5050
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Calnor of EL Paseo, Inc.
    Date Received
    May 7, 1984
    Decision Date
    July 17, 1984
    Product Code
    HCC
    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
    HCC Device, Biofeedback

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    Other Clearances by Calnor of EL Paseo, Inc.

    K Number Device Name
    K842353 TEMPERATURE 132
    K842288 EEG 130
    K842354 EMG MODEL 133
    K834152 ETHYLENE OXIDE DETECTOR GLD-1-07
    K771577 CLINICAL EMG MODEL 133