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

    PATIENT MONITOR

    K Number: K101692 · Decision Jun 28, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    424
    Applicant Total
    12
    Review Days
    377

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    Basic Information

    Device Name
    PATIENT MONITOR
    K Number
    K101692
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Contec Medical System Co., Ltd.
    Date Received
    June 16, 2010
    Decision Date
    June 28, 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)

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    Other Clearances by Contec Medical System Co., Ltd.

    K Number Device Name
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    K110156 AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER,
    K110774 ELECTRONIC SPHYGMOMANOMETER
    K101127 PATIENT MONITOR, MODEL PM50
    K090936 SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A
    K090671 PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D
    K082480 CONTEC POCKET FETAL DOPPLER
    K082641 FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL
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