LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K983783
    Device Name
    HEATED HUMIDIFIER
    Manufacturer
    PEGASUS RESEARCH CORP.
    Date Cleared
    2000-10-24

    (728 days)

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

    The Patient End Humidifier is intended to add moisture and to warm the breathing gases for administration to a patient.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for a "Heated Humidifier" with the device name "PATIENT-END HUMIDIFIER" (K983783). It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter is an FDA clearance, stating the device is substantially equivalent to a predicate device, which allows it to be marketed.

    Therefore, I cannot provide the requested information based on this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1