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510(k) Data Aggregation

    K Number
    K033040
    Device Name
    PHOENIX INFANT RADIANT WARMER, MODEL 100NWS
    Manufacturer
    INTERNATIONAL HOSPITAL SUPPLY CO.
    Date Cleared
    2003-12-17

    (79 days)

    Product Code
    FMT
    Regulation Number
    880.5130
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PHOENIX INFANT RADIANT WARMER, MODEL 100NWS

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

    The PHOENIX Infant Radiant Warmer consists of an infrared heating element placed over an infant in order to maintain the infant's body temperature at a level determined by the caregiver by means of radiant heat. It is designed to be used in those areas of the health care facility that provide neonatal and infant care.

    Device Description

    The PHOENIX Infant Radiant Warmer consists of an infrared heating element placed over an infant in order to maintain the infant's body temperature at a level determined by the caregiver by means of radiant heat.

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the PHOENIX Infant Radiant Warmer, Model 100NWS. This document provides regulatory information and approval for marketing the device, but it does not contain any information about acceptance criteria, study details, performance metrics, ground truth, or sample sizes.

    Therefore, I cannot fulfill your request for the detailed technical information regarding the device's performance, studies, and ground truth establishment based on the provided text. The document is strictly a regulatory communication for market approval.

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