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510(k) Data Aggregation

    K Number
    K982216
    Device Name
    ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522
    Manufacturer
    BRAEBON MEDICAL CORP.
    Date Cleared
    1998-09-11

    (80 days)

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

    ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522

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

    An indicator of respiratory effort for recording onto a data acquisition system.

    Device Description

    Ultima Respiratory Effort Sensor, 0520 and 0522

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the Ultima Respiratory Effort Sensor Models 0520 and 0522. It primarily states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

    While it mentions the device's intended use and target population, it lacks the detailed information required to answer your specific questions regarding acceptance criteria, study methodologies, and performance metrics.

    Specifically, the document does not contain:

    1. A table of acceptance criteria or reported device performance.
    2. Details about sample sizes, data provenance, or ground truth establishment for any test sets.
    3. Information on expert qualifications, adjudication methods, or MRMC studies.
    4. Data on standalone algorithm performance or training set details.

    Therefore, I cannot provide the requested information based on the provided text.

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