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510(k) Data Aggregation

    K Number
    K031064
    Device Name
    INVACARE POLARIS EX CPAP, MODEL ISP3000
    Manufacturer
    INVACARE CORP.
    Date Cleared
    2004-03-12

    (344 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K021861,K982242
    Why did this record match?
    Device Name :

    INVACARE POLARIS EX CPAP, MODEL ISP3000

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

    The intended function and use of the Invacare Polaris EX CPAP is to provide positive airway pressure therapy to adult patients (>30kg.) for the treatment of Obstructive Sleep Apnea (OSA).

    Device Description

    All units consist of a flow generator (blower), patient circuit, exhalation port, humidifier (if desired), microprocessor based control system, pressure sensor and operate on 120 volts AC, 60Hz

    AI/ML Overview

    This document does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria. It is a 510(k) summary for the Invacare Polaris EX CPAP, primarily focused on establishing substantial equivalence to predicate devices for regulatory clearance. It lacks detailed performance data, study design, or ground truthing methods.

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