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510(k) Data Aggregation

    K Number
    K203620
    Device Name
    Aneroid Sphygmomanometer
    Date Cleared
    2021-03-23

    (102 days)

    Product Code
    Regulation Number
    870.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    Wuxi Exanovo Medical Instrument Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Aneroid Sphygmomanometer is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on children or adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.
    Device Description
    The proposed device is composed of manometer, cuff bladder, inflation bulb and optioned stethoscopes. It is available in four models, MC-20A, MC-30 and MC-50, which are different in cuff material, cuff bladder material and stethoscope option. The aneroid sphygmomanometer should be used in conjunction with a stethoscope. For model MC-50, there are three types of stethoscope for option: Single Head, Dual Head and Sprague Rappaport stethoscope, while the other models of the proposed device do not have stethoscope in configuration. There are also six sizes of cuff for each model device in order to fit varies arm circumference of user. The proposed device is Over-The-Counter use, non-sterile, reusable device.
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