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    K Number
    K974879
    Device Name
    MODEL 7410 VOYAGER
    Manufacturer
    HEALTHDYNE TECHNOLOGIES, INC.
    Date Cleared
    1998-06-29

    (181 days)

    Product Code
    BZD,MAR
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODEL 7410 VOYAGER

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

    The Model 7410 series CPAP system is a device that is intended to provide continuous positive airway pressure to adults who experience obstructive sleep apnea (OSA). The device will automatically adjust and maintain airway pressure based on the continuing needs of the patient. The device may be used in either the home or hospital environment.

    Device Description

    Model 7410 Series CPAP System

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA to Healthdyne Technologies for their Model 7410 Voyager CPAP System. It states that the device is substantially equivalent to a legally marketed predicate device.

    This document does not contain information about the acceptance criteria and the study details (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details) that would prove the device meets specific performance criteria. It primarily focuses on regulatory clearance based on substantial equivalence.

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