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

    AUDIO MONITOR-MODEL 8309

    K Number: K780538 · Decision Apr 19, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    22
    Applicant Total
    19
    Review Days
    16

    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
    AUDIO MONITOR-MODEL 8309
    K Number
    K780538
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1845
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Life-Tech Instruments, Inc.
    Date Received
    April 3, 1978
    Decision Date
    April 19, 1978
    Product Code
    GWK
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GWK Conditioner, Signal, Physiological

    Similar 510(k) Clearances

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

    ACTICAL

    FDA 510(k)
    FDA Class 2 ·Neurology

    VITALSENSE XHR

    FDA 510(k)
    FDA Class 2 ·Neurology

    ACTIHEART

    FDA 510(k)
    FDA Class 2 ·Neurology

    MINI-LOGGER SERIES 2000

    FDA 510(k)
    FDA Class 2 ·Neurology

    NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300

    FDA 510(k)
    FDA Class 2 ·Neurology

    VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM

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

    Other Clearances by Life-Tech Instruments, Inc.

    K Number Device Name
    K812177 LIFE-TECH #1857 PRESSURE/POLOT MODULE
    K812179 LIFE-TECH #1753 BIOFEEDBACK TRAINER
    K812180 LIFE-TECH #5102 VISULAB
    K812178 LIFE-TECH #'S 1106/1156 UROLABS
    K800112 AMBLYOPIA TRAINER
    K790663 MODEL 1750 STANDING URINAL
    K790664 MODEL 1309 AUDIO MONITOR
    K781476 MULAR GOLD LEAF ELECTRODE MODEL 7501
    K781461 MODEL 7320 VISUAL STIMULATOR
    K781475 ELECTRODE IMPEDANCE TESTER-MODEL 500
    Search all 19 clearances from Life-Tech Instruments, Inc. →