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

    TRUSCOPE SERIES PATIENT MONITOR

    K Number: K131763 · Decision Jul 15, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    424
    Applicant Total
    21
    Review Days
    28

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    Basic Information

    Device Name
    TRUSCOPE SERIES PATIENT MONITOR
    K Number
    K131763
    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
    June 17, 2013
    Decision Date
    July 15, 2013
    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)

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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
    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. →