BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    PATIENT MONITOR

    K Number: K112803 · Decision Oct 24, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    424
    Applicant Total
    21
    Review Days
    27

    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
    PATIENT MONITOR
    K Number
    K112803
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guangdong Biolight Meditech Co., Ltd.
    Date Received
    September 27, 2011
    Decision Date
    October 24, 2011
    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 Guangdong Biolight Meditech Co., Ltd.

    K Number Device Name
    K181919 Patient Monitor
    K170514 Central Monitoring System
    K162234 Truscope Ultra Patient Monitor
    K160349 Electronic Sphygmomanometer
    K153580 Central Monitoring System
    K153135 VITAL SIGNS MONITOR
    K152739 Electronic Thermometer
    K151287 Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D
    K131858 DIGITAL ELECTROCARDIOGRAPH
    K131762 HANDHELD MONITOR
    Search all 21 clearances from Guangdong Biolight Meditech Co., Ltd. →