BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    AUTOMATIC BLOOD PRESSURE MONITOR

    K Number: K140762 · Decision Jul 2, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    13
    Review Days
    462

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    Basic Information

    Device Name
    AUTOMATIC BLOOD PRESSURE MONITOR
    K Number
    K140762
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jawon Medical Co., Ltd.
    Date Received
    March 27, 2014
    Decision Date
    July 2, 2015
    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 Jawon Medical Co., Ltd.

    K Number Device Name
    K140045 BODY COMPOSITION ANALYZER
    K092432 AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L)
    K092431 BODY COMPOSITION ANALYZER, MODEL: IOI 353
    K072325 BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205
    K071884 BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900
    K062462 NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L
    K053556 BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5
    K013876 INFRARED EAR THERMOMETER, MODEL DX-707
    K002722 DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505
    K000675 MANUAL DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-502
    Search all 13 clearances from Jawon Medical Co., Ltd. →