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510(k) Data Aggregation

    K Number
    K982135
    Device Name
    OSCILLOMATE EMS NIBP MONITOR MODEL 9001
    Manufacturer
    CAS MEDICAL SYSTEMS, INC.
    Date Cleared
    1998-09-15

    (90 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Abbreviated
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OSCILLOMATE EMS NIBP MONITOR MODEL 9001

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

    The Oscillornate 9001 Monitor non-invasively measures the blood pressure of adult , and pediatric patients primarily in the emergency care environment. The monitor automatically inflates an occluding cuff and, using the Oscillometric measurement technique, determines systolic, diastolic, mean arterial pressure and pulse rate.

    Device Description

    Oscillomate 9001 Non-invasive Blood Pressure Monitor

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the Oscillomate EMS NIBP Monitor Model 9001. It does not contain information on acceptance criteria, reported device performance, or details of a study proving the device meets acceptance criteria.

    Therefore, I cannot provide the requested information based on the provided text. The document primarily focuses on the regulatory clearance of the device due to its substantial equivalence to a legally marketed predicate device.

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