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510(k) Data Aggregation

    K Number
    K953893
    Device Name
    PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM
    Manufacturer
    BIOMEDICAL SENSORS, INC.
    Date Cleared
    1997-11-04

    (810 days)

    Product Code
    CCC
    Regulation Number
    868.1150
    Type
    Traditional
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMEDICAL SENSORS, INC.

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

    Not Found

    Device Description

    Fluorescent Paratrend 7 Intravascular Monitoring System (MPM7000S)

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain any information about acceptance criteria, device performance, specific studies, sample sizes, ground truth establishment, or expert involvement for a device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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