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

    DM100 (DISTAL MONITOR - 100)

    K Number: K884135 · Decision Jan 17, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    171
    Applicant Total
    1
    Review Days
    109

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    Basic Information

    Device Name
    DM100 (DISTAL MONITOR - 100)
    K Number
    K884135
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5050
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Bio.Logic, Inc.
    Date Received
    September 30, 1988
    Decision Date
    January 17, 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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