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

    AS/3 NMT MODULE

    K Number: K955026 · Decision Apr 28, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    28
    Applicant Total
    5
    Review Days
    543

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    Basic Information

    Device Name
    AS/3 NMT MODULE
    K Number
    K955026
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2775
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Datex Medical Instrumentation, Inc.
    Date Received
    November 2, 1995
    Decision Date
    April 28, 1997
    Product Code
    KOI
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KOI Stimulator, Nerve, Peripheral, Electric

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