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

    Truscope Ultra Patient Monitor

    K Number: K162234 · Decision Jan 4, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    21
    Review Days
    148

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    Basic Information

    Device Name
    Truscope Ultra Patient Monitor
    K Number
    K162234
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Guangdong Biolight Meditech Co., Ltd.
    Date Received
    August 9, 2016
    Decision Date
    January 4, 2017
    Product Code
    MWI
    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
    MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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    Other Clearances by Guangdong Biolight Meditech Co., Ltd.

    K Number Device Name
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    K152739 Electronic Thermometer
    K151287 Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D
    K131858 DIGITAL ELECTROCARDIOGRAPH
    K131762 HANDHELD MONITOR
    K131941 FETAL MONITORS
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