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

    BRACKMANN EMG MONITORING SYSTEM

    K Number: K895838 · Decision Mar 27, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    96
    Applicant Total
    6
    Review Days
    176

    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
    BRACKMANN EMG MONITORING SYSTEM
    K Number
    K895838
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1820
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Wr Medical Electronics Co.
    Date Received
    October 2, 1989
    Decision Date
    March 27, 1990
    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

    Similar 510(k) Clearances

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

    Evala Nerve Stimulator (EPNR002)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Bioscope Neuromonitor Device

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    EARP Nerve Cuff Electrode

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Disposable Laryngeal Electrodes

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    View all

    Other Clearances by Wr Medical Electronics Co.

    K Number Device Name
    K092809 HRV ACQUIRE
    K063560 HILGER DUAL-STIM NERVE STIMULATOR
    K000574 IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE)
    K992874 Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM
    K910624 CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4