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

    MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR

    K Number: K954120 · Decision Apr 2, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    204
    Same Product Code
    301
    Applicant Total
    5
    Review Days
    579

    Basic Information

    Device Name
    MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR
    K Number
    K954120
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    MAGNETIC RESONANCE EQUIPMENT CORP.
    Date Received
    September 1, 1995
    Decision Date
    April 2, 1997
    Product Code
    CCK
    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
    CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

    Similar 510(k) Clearances

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

    TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AIM (N/A)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Oxy2Pro

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Endure ETCO2/02 Nasal Cannula

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

    Other Clearances by MAGNETIC RESONANCE EQUIPMENT CORP.

    K Number Device Name
    K003982 TEMPERATURE FUNCTION, MODEL 9500 MULTIGAS MONITOR
    K983250 INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR
    K924285 MODEL 3500 MR-COMPATIBLE PULSE OXIMETER
    K924282 MODEL 320 MR-COMPATIBLE PULSE OXIMETER