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510(k) Data Aggregation

    K Number
    K063690
    Device Name
    COLIN PRESS MATE, MODEL BP S510
    Manufacturer
    OMRON HEALTHCARE, INC.
    Date Cleared
    2007-05-09

    (148 days)

    Product Code
    MHX,CCK,DPS,DQA,DSK,DXN
    Regulation Number
    870.1025
    Type
    Special
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    COLIN PRESS MATE, MODEL BP S510

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Colin Press Mate, Model BP S510 is intended to be used to monitor electrocardiography (ECG), heart rate (HR), noninvasive blood pressure (systolic, diastolic and mean arterial pressures) (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), respiration (RR), body temperature (Temp), invasive blood pressure (IBP) and capnography (EtCO2 and InCO2 ).

    Device Description

    Not Found

    AI/ML Overview

    This is an FDA premarket notification letter for the Colin Press Mate, Model BP S510. This type of document typically does not contain the detailed study information you are requesting. The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which means specific performance data and acceptance criteria are usually not presented in this summary letter itself.

    To answer your questions, you would need access to the full 510(k) submission document (K063690), which would contain the detailed pre-clinical and clinical study reports. The FDA letter only serves as an approval based on the information provided in that submission.

    Therefore, I cannot provide the requested information from the provided text.

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