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    K Number
    K013856
    Device Name
    PMH 1000 HEATED HUMIDIFIER
    Manufacturer
    PEGASUS RESEARCH CORP.
    Date Cleared
    2003-02-21

    (472 days)

    Product Code
    BTT
    Regulation Number
    868.5450
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PMH 1000 HEATED HUMIDIFIER

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

    The PMH 1000 Heated Humidifier is intended to add moisture and to warm the breathing gases for administration to a patient.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the PMH 1000 Heated Humidifier. This type of document does not contain the information requested about acceptance criteria, study details, or ground truth for a device's performance.

    The letter confirms that the device is substantially equivalent to a predicate device and can be marketed, subject to general controls. It's a regulatory approval letter, not a technical report or scientific study summary.

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

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