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510(k) Data Aggregation

    K Number
    K971260
    Device Name
    SULLIVAN HUMIDAIRE HEATED HUMIDIFIER
    Manufacturer
    RESMED CORP.
    Date Cleared
    1997-09-04

    (153 days)

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

    SULLIVAN HUMIDAIRE HEATED HUMIDIFIER

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

    The HumidAire™ Heated Humidifier is indicated for the humidification and warming of the air from nasal Continuous Positive Airway Pressure (CPAP) and bi-level systems, but not autoset systems. The HumidAire is for prescription use only.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a medical device (SULLIVAN® HumidAire™ Heated Humidifier), and it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.

    The letter only confirms that the device is substantially equivalent to a pre-amendment device and can be marketed. It does not delve into the specific details of performance testing as you've requested.

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