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510(k) Data Aggregation

    K Number
    K020700
    Device Name
    PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY
    Manufacturer
    PEGASUS RESEARCH CORP.
    Date Cleared
    2004-04-26

    (784 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 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY

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

    The PMH Humidifier is intended to add moisture and To warm the breathing gases for administration to a patient. The humidifier is intended for use with flows of 5 liters per Minute or more through the humidifier.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a PMH 5000 Heated Humidifier for Respiratory Therapy. This document is a regulatory approval for a medical device that adds moisture and warms breathing gases for patients.

    It does not contain information about acceptance criteria, device performance metrics, or study design for an AI/ML-driven device. The text is a formal letter confirming that the device is substantially equivalent to legally marketed predicate devices, which is a regulatory pathway for hardware-based medical devices.

    Therefore, I cannot extract the requested information regarding AI/ML device performance and study details from this document. The questions you've asked are applicable to AI-driven diagnostic or prognostic devices, not a respiratory gas humidifier.

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