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510(k) Data Aggregation

    K Number
    K974792
    Device Name
    CS/3(TM) MONITORS*
    Manufacturer
    DATEX-ENGSTROM, INC.
    Date Cleared
    1998-06-02

    (162 days)

    Product Code
    DSI
    Regulation Number
    870.1025
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CS/3(TM) MONITORS*

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

    The CS/3™ Monitors are indicated for multiparameter patient monitoring in all hospital patients.

    Device Description

    CS/3™ Monitors* * Includes CS/3™ Critical Care Monitor and CS/3™ Compact Monitor.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the Datex Engstrom, Inc. CS/3™ Monitors. It indicates the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot provide the requested information. The document primarily focuses on regulatory approval and indications for use.

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