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

    BMS-2000 MOBILE EEG SYSTEM

    K Number: K891405 · Decision Aug 2, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    19
    Applicant Total
    111
    Review Days
    141

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    Basic Information

    Device Name
    BMS-2000 MOBILE EEG SYSTEM
    K Number
    K891405
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1855
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Buckman Co., Inc.
    Date Received
    March 14, 1989
    Decision Date
    August 2, 1989
    Product Code
    GYE
    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
    GYE Encephalogram Telemetry System

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