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

    TELEPHONE TRANSMITTER T-10 EEG

    K Number: K833236 · Decision Nov 29, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    19
    Applicant Total
    14
    Review Days
    105

    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
    TELEPHONE TRANSMITTER T-10 EEG
    K Number
    K833236
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1855
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Pharmaquest Corp.
    Date Received
    August 16, 1983
    Decision Date
    November 29, 1983
    Product Code
    GYE
    Advisory Committee
    Neurology
    Review Advisory Committee
    RA
    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 Pharmaquest Corp.

    K Number Device Name
    K945519 FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM
    K833880 TELEPHONIC RECEIVER R-10 EEG
    K830705 MINI LANCET-BLOOD LANCET
    K822976 HYPOCOUNT A
    K822486 HOME BLOOD GLUCOSE MONITOR
    K820248 RODDER VOLUME VENTILATOR
    K812849 PTT-200 TELEPHONIC PULMONARY TRANSMITT
    K812850 PTT-200 PULMONARY RECEIVER/MICROPROCES
    K813010 EEG TELEPHONE TRANSMITTER, MODEL #T-7
    K812683 NEONATE FLEXFLOAT
    Search all 14 clearances from Pharmaquest Corp. →