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510(k) Data Aggregation

    K Number
    K030071
    Device Name
    SERVO GUARD, MODEL 64 81 290 EH88E
    Manufacturer
    MAQUET, INC.
    Date Cleared
    2004-04-26

    (474 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K871366,K002839
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAQUET, INC.

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

    The Servo Guard is a disposable single-use device that provides filtration for reducing possible cross contamination between patient and equipment. The device is intended for adult, pediatric and infant populations. The device is indicated for use by qualified medical personnel only.

    Device Description

    The Servo Guard is an efficient bacterial and viral filter for applications in respiratory care and anesthesia. The Servo Guard is a disposable single-use device that provides filtration for reducing possible cross contamination between patient and equipment.

    AI/ML Overview

    This document is a 510(k) summary for the Servo Guard bacterial and viral filter. It does not contain information about acceptance criteria or a study proving that the device meets such criteria in the format requested. The document describes the device, its intended use, and claims substantial equivalence to predicate devices, but lacks details on performance studies with specific statistical metrics.

    Therefore, I cannot extract the requested information from the provided text.

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