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510(k) Data Aggregation

    K Number
    K050040
    Device Name
    MS-753 MARS INFLATE-READ BLOOD PRESSURE MONITOR
    Manufacturer
    MARS MEDICAL PRODUCTS
    Date Cleared
    2005-03-30

    (82 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.
      1. 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

    AI/ML Overview

    This document is a 510(k) clearance letter for the "MS-930 Mars Inflate-Read Blood Pressure Monitor". It does not contain the acceptance criteria and study details as requested. A 510(k) clearance letter typically states that a device is substantially equivalent to a predicate device, allowing it to be marketed, but it does not detail the specific performance studies and acceptance criteria from the submission itself.

    Therefore, I cannot extract the requested information from the provided text. The document confirms the clearance of the device and its indications for use, but not the technical study details.

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