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

    TRANSTEK BLOOD PRESSURE MONITOR

    K Number: K120058 · Decision Jan 31, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    9
    Review Days
    22

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    Basic Information

    Device Name
    TRANSTEK BLOOD PRESSURE MONITOR
    K Number
    K120058
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zhongshan Transtek Electronics Co., Ltd.
    Date Received
    January 9, 2012
    Decision Date
    January 31, 2012
    Product Code
    DXN
    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
    DXN System, Measurement, Blood-Pressure, Non-Invasive

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    Other Clearances by Zhongshan Transtek Electronics Co., Ltd.

    K Number Device Name
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    K123669 TRANSTEK WRIST BLOOD PRESSURE MONITOR
    K122482 TRANSTEK WRIST BLOOD PRESSURE MONITOR
    K121971 WITHINGS, SMART BODY SCALE
    K112932 TRANSTEK
    K101681 TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995
    K102191 TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZER