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

    BRAEGEN III 10-CHANNEL TRANSMITTER-

    K Number: K832304 · Decision Aug 31, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    19
    Applicant Total
    2
    Review Days
    48

    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
    BRAEGEN III 10-CHANNEL TRANSMITTER-
    K Number
    K832304
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1855
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Electro-Bio-Medical Services, Inc.
    Date Received
    July 14, 1983
    Decision Date
    August 31, 1983
    Product Code
    GYE
    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
    GYE Encephalogram Telemetry System

    Similar 510(k) Clearances

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

    WIRELESS EEG RECORDING SYSTEM MODEL W32

    FDA 510(k)
    FDA Class 2 ·Neurology

    DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER

    FDA 510(k)
    FDA Class 2 ·Neurology

    MODEL 219 TELEMETRY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    BMS-2000 MOBILE EEG SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER

    FDA 510(k)
    FDA Class 2 ·Neurology

    ISO-100 ISOLATION AMPLIFIER

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

    Other Clearances by Electro-Bio-Medical Services, Inc.

    K Number Device Name
    K811093 BRAEGEN EEG TRANSMITTER/RECEIVER SYS