LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K960167
    Device Name
    SYSTEM, THERMAL REGULATING 74-DWJ
    Manufacturer
    AUGUSTINE MEDICAL, INC.
    Date Cleared
    1996-06-17

    (153 days)

    Product Code
    DWJ
    Regulation Number
    870.5900
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SYSTEM, THERMAL REGULATING 74-DWJ

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

    Not Found

    Device Description

    The device is a Class II device, System Thermal Regulating 74 DWG, Patient Warming System called the Bair Hugger® Total Temperature Management® System - Model 505 Warming Unit.

    AI/ML Overview

    This is a 510(k) premarket notification for a medical device (Bair Hugger® Total Temperature Management® System - Model 505 Warming Unit), not a study describing the validation of an AI/ML device. Therefore, the requested information about acceptance criteria, study design, and performance metrics for an AI device is not available in the provided text.

    The document discusses the safety and effectiveness of a patient warming system, comparing it to a predicate device (Model 500). It highlights safety concerns (tissue injury, hyperthermia, contamination) and the preventive measures implemented in the device. The "effectiveness" section only states that the Model 505 delivers air temperatures within the same specifications as the Model 500.

    To answer your request, I would need a document related to the validation of an AI/ML medical device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1