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510(k) Data Aggregation

    K Number
    K993036
    Device Name
    ZOLL M SERIES ETCO2 OPTION
    Manufacturer
    ZOLL MEDICAL CORP.
    Date Cleared
    2000-02-28

    (172 days)

    Product Code
    MKJ,DAT
    Regulation Number
    870.5310
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ZOLL M SERIES ETCO2 OPTION

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

    The ZOLL M Series EtCO2 option with Novametrix technology and Capnostal® sensor is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in patients requiring ventilator support, transport, and anesthesia.

    Device Description

    ZOLL M Series EtCO2 Option

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the ZOLL M Series EtCO2 Option. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

    Therefore, I cannot provide the requested information based on the provided text.

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