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

    DOLOTENS DENTAL TM 1

    K Number: K043373 · Decision Sep 2, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    18
    Applicant Total
    1
    Review Days
    268

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    Basic Information

    Device Name
    DOLOTENS DENTAL TM 1
    K Number
    K043373
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    890.1375
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neuromuscular Technologies, Inc.
    Date Received
    December 8, 2004
    Decision Date
    September 2, 2005
    Product Code
    KZM
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KZM Device, Muscle Monitoring

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