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510(k) Data Aggregation

    K Number
    K191209
    Device Name
    Aneroid Type Blood Pressure Kit
    Date Cleared
    2019-06-18

    (43 days)

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

    Dongguan Mars Medical Products Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended to be used by medical professionals or in the measurement of systolic and diastolic pressure. The models MS-200, MS-200M are intended to be manually attached to a patient and manually inflated along with a manual method.
    Device Description
    Aneroid Type Blood Pressure Kit, models MS-200D and MS-200M are a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. The proposed device has three models, MS-200/MS-200D/MS-200M. The three models have same intended use, same design and measuring principle, same measuring range and same main components. The only differences among the three models are assembly accessories for fixation and installation of the aneroid sphygmomanometer.
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    K Number
    K050040
    Device Name
    MS-753 MARS INFLATE-READ BLOOD PRESSURE MONITOR
    Date Cleared
    2005-03-30

    (82 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARS MEDICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    1. The device is designed to provide signals from which systolic and diastolic pressures can be derived through the use of the Oscillometric method. \ The device also measure pulse rate. - 2. The device is for adult use only. - The device is for use at home or while traveling. 3.
    Device Description
    MS-753 Mars Inflate-Read Blood Pressure Monitor
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    K Number
    K050039
    Device Name
    MS-930 MARS INFLATE-READ BLOOD PRESSURE MONITOR
    Date Cleared
    2005-03-25

    (77 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARS MEDICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    1. The device is designed to provide signals from which systolic and diastolic pressures can be derived through the use of the Oscillometric method. The device also measure pulse rate. 2. The device is for adult use only. 3. The device is for use at home or while traveling.
    Device Description
    Not Found
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    K Number
    K032825
    Device Name
    VITAL VISION ARTERIAL HARDNESS AND BLOOD PRESSURE MONITOR
    Date Cleared
    2004-12-10

    (457 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARS MEDICAL PRODUCTS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - 1. The device is designed to provide signals from which systolic, diastolic pressures and H-Value (arterial stiffness index) can be derived through the use of the Oscillometric method. The device also measure pulse rate. - 2. Adult Use Only - 3. For use in the clinical setting or home use under the direction of a physician.
    Device Description
    The device is designed to provide signals from which systolic, diastolic pressures and H-Value (arterial stiffness index) can be derived through the use of the Oscillometric method. The device also measure pulse rate.
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    K Number
    K980845
    Device Name
    MS-900S, MS-900SPM & MS-900SFM
    Date Cleared
    1998-12-14

    (285 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARS MEDICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Mars MS-900S, MS-900SFM & MS-900SPM Auto Inflation Wrist Blood Pressure Monitors are designed to provide signals from which systolic and diastolic pressures can be derived through the use of the oscillometric method. The devices also measure pulse rate.
    Device Description
    Mars MS-900S, MS-900SFM & MS-900SPM Auto Inflation Wrist Digital Blood Pressure Monitors
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