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510(k) Data Aggregation

    K Number
    K062664
    Device Name
    HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004
    Manufacturer
    APEX MEDICAL CORP.
    Date Cleared
    2006-12-06

    (90 days)

    Product Code
    BTT
    Regulation Number
    868.5450
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K120035
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    HumidCare Heated Humidifier is for use with Apex Medical Corp.'s CPAP 9S-003 system. It is designed to increase the humidity of the air from the CPAP thereby relieving the symptoms of a dry nose and throat that some people may experience.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "HumidCare Heated Humidifier." This document does not contain information regarding acceptance criteria or a study proving the device meets those criteria. It is a regulatory approval letter that confirms substantial equivalence to a predicate device.

    Therefore, I cannot extract the requested information.

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