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

    AL-200B MUSCLE ACTIVITY INTEGRATOR

    K Number: K880976 · Decision Apr 13, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    74
    Applicant Total
    2
    Review Days
    36

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    Basic Information

    Device Name
    AL-200B MUSCLE ACTIVITY INTEGRATOR
    K Number
    K880976
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.1375
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Aaron Laboratories, Inc.
    Date Received
    March 8, 1988
    Decision Date
    April 13, 1988
    Product Code
    IKN
    Advisory Committee
    Physical Medicine
    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
    IKN Electromyograph, Diagnostic

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    Other Clearances by Aaron Laboratories, Inc.

    K Number Device Name
    K880977 ADR-2000 AMBULATORY DATA RECORDING SYSTEM