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

    BIOFEEDBACK EEG1/2, EEG ULTRA LOW NOISE, SYC1

    K Number: K884853 · Decision Feb 2, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    171
    Applicant Total
    6
    Review Days
    76

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    Basic Information

    Device Name
    BIOFEEDBACK EEG1/2, EEG ULTRA LOW NOISE, SYC1
    K Number
    K884853
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5050
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Moe
    Date Received
    November 18, 1988
    Decision Date
    February 2, 1989
    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 Moe

    K Number Device Name
    K884849 BIOFEEDBACK DEVICE ACCESS. PI1,2,3,4,5/LIGHT BAR
    K884851 BIOFEEDBACK DEVICE TG3, TG4
    K884848 BASIC BIOFEEDBACK,TMG4.1, SA1/2, EEG4/5, IR RECEIV
    K884850 BIOFEEDBACK TMG1, 4, BIO1, PA1, 2, BA1/BA30
    K884852 BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI.