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

    AXOSTIM

    K Number: K883807 · Decision Feb 9, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    62
    Applicant Total
    8
    Review Days
    154

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    AXOSTIM
    K Number
    K883807
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2775
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Singer Medical Products, Inc.
    Date Received
    September 8, 1988
    Decision Date
    February 9, 1989
    Product Code
    BXN
    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
    BXN Stimulator, Nerve, Battery-Powered

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (BXN), ordered by most recent decision date.

    STIMPOD NMS450 Nerve Stimulator

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MultiStim ECO

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MiniStim MS-IVB Peripheral Nerve Stimulator

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    STIMPOD ST2-3010 NERVE STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by Singer Medical Products, Inc.

    K Number Device Name
    K905035 AXOSTIM NERVE STIMULATOR, MODIFICATION
    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