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

    Central Monitoring System

    K Number: K153580 · Decision Sep 7, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    213
    Applicant Total
    21
    Review Days
    267

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    Basic Information

    Device Name
    Central Monitoring System
    K Number
    K153580
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2740
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guangdong Biolight Meditech Co., Ltd.
    Date Received
    December 15, 2015
    Decision Date
    September 7, 2016
    Product Code
    HGM
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HGM System, Monitoring, Perinatal

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    Other Clearances by Guangdong Biolight Meditech Co., Ltd.

    K Number Device Name
    K181919 Patient Monitor
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    K162234 Truscope Ultra Patient Monitor
    K160349 Electronic Sphygmomanometer
    K153135 VITAL SIGNS MONITOR
    K152739 Electronic Thermometer
    K151287 Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D
    K131858 DIGITAL ELECTROCARDIOGRAPH
    K131762 HANDHELD MONITOR
    K131941 FETAL MONITORS
    Search all 21 clearances from Guangdong Biolight Meditech Co., Ltd. →