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

    CARESCAPE MONITOR B850

    K Number: K092027 · Decision Aug 28, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    424
    Applicant Total
    136
    Review Days
    53

    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
    CARESCAPE MONITOR B850
    K Number
    K092027
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ge Medical Systems Information Technologies
    Date Received
    July 6, 2009
    Decision Date
    August 28, 2009
    Product Code
    MHX
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

    Similar 510(k) Clearances

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

    Radius VSM and Accessories

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    M12 Telemetry System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Vista CMS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)

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

    Other Clearances by Ge Medical Systems Information Technologies

    K Number Device Name
    K120770 QT GUARD PLUS ANALYSIS SYSTEM
    K102426 CARESCAPE MODEL V100 VITAL SIGNS MONITOR
    K092369 12SL ECG ANALYSIS PROGRAM
    K093141 MARS HOLTER ANALYSIS WORKSTATION
    K090702 MODIFICATION TO DASH 2500 PATIENT MONITOR
    K083750 CAPNOSTAT / CAPNOFLEX CO2 SYSTEM
    K083639 MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE
    K082851 MULTLINK CABLE AND LEADWIRE SYSTEM
    K081437 MAC 1600 ECG ANALYSIS SYSTEM
    K080251 APEXPRO TELEMETRY SYSTEMS
    Search all 136 clearances from Ge Medical Systems Information Technologies →