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510(k) Data Aggregation

    K Number
    K051779
    Device Name
    ANDROFLOW - RESPIRATORY RATE MONITOR
    Manufacturer
    ANDROMED, INC.
    Date Cleared
    2005-09-30

    (91 days)

    Product Code
    BZQ
    Regulation Number
    868.2375
    Type
    Abbreviated
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ANDROFLOW - RESPIRATORY RATE MONITOR

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

    Androflo™ is intended for use as an adjunct to patient assessment in continuous monitoring of respiratory rate (breathing frequency).

    Androflo™ is indicated for clinical use in adult patients under the supervision of qualified health care professionals trained in the use of the equipment.

    Androflo™ is not intended for home use or for use as an apnea monitor.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "ANDROFLOW-RESPIRATORY RATE MONITOR." It confirms that the device has been found substantially equivalent to a predicate device. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot fulfill your request for this information based on the provided text. To answer your questions, I would need a different document, such as a summary of safety and effectiveness (SSE) or a clinical study report that was part of the 510(k) submission.

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