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

    ANTENSE ANTI-TENSION DEVICE

    K Number: K834110 · Decision Feb 4, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    171
    Applicant Total
    3
    Review Days
    67

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    Basic Information

    Device Name
    ANTENSE ANTI-TENSION DEVICE
    K Number
    K834110
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5050
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Bio Sig Instruments, Inc.
    Date Received
    November 29, 1983
    Decision Date
    February 4, 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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