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

    AXOSTIM NERVE STIMULATOR, MODIFICATION

    K Number: K905035 · Decision Apr 19, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    96
    Applicant Total
    8
    Review Days
    176

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    Basic Information

    Device Name
    AXOSTIM NERVE STIMULATOR, MODIFICATION
    K Number
    K905035
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1820
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Singer Medical Products, Inc.
    Date Received
    October 25, 1990
    Decision Date
    April 19, 1991
    Product Code
    ETN
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ETN Stimulator, Nerve

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    Other Clearances by Singer Medical Products, Inc.

    K Number Device Name
    K896909 MD5 AUTOMATIC AUDIOMETER
    K894748 IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P
    K895785 AUDIOMETER MODEL MD-4, MD-4P
    K895783 IMPEDANCE ANALYZER MODELS MD-2, MD-P
    K895784 IMPEDANCE ANALYZER/AUDIOMETER MODEL MD-3
    K896368 MODIFIED AXOSTIM
    K883807 AXOSTIM