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    K Number
    K982992
    Device Name
    ZOLL M SERIES SPO2 OPTION
    Manufacturer
    ZOLL MEDICAL CORP.
    Date Cleared
    1999-03-11

    (196 days)

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

    ZOLL M SERIES SPO2 OPTION

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

    The ZOLL M Series Pulse Oximeter with Masimo SET® technology and the LNOP® Series of Sensors are indicated for the continuous noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate during both no motion and patient motion conditions for pediatric and neonatal patients, in a hospital and pre-hospital environment.

    Device Description

    Not Found

    AI/ML Overview

    The provided document does not contain acceptance criteria or a study proving the device meets acceptance criteria.

    The document, K982992, is primarily a Class III Summary and a 510(k) clearance letter from the FDA for a ZOLL M-Series Defibrillator SpO2 Option. It focuses on:

    • Identifiying commonly reported problems for defibrillators and pacemakers (MDRs and general complaints) from advisory documents and literature searches. This is to demonstrate the manufacturer's awareness of potential issues.
    • A formal FDA letter granting 510(k) clearance based on substantial equivalence to predicate devices.
    • Indications for Use for the SpO2 option.

    Therefore, I cannot provide the requested information. The document details problems associated with similar devices and the regulatory clearance process, but not performance criteria or a study demonstrating the specific device's performance against such criteria.

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