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510(k) Data Aggregation

    K Number
    K040853
    Device Name
    PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101
    Manufacturer
    INTERNATIONAL HOSPITAL SUPPLY CO.
    Date Cleared
    2004-06-21

    (81 days)

    Product Code
    LBI
    Regulation Number
    880.5700
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101

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

    The PHOENIX Neonatal Phototherapy Unit CFL 101 provides light therapy for the treatment of hyperbilirubinemia, commonly light therapy for and jaundice, during the newborn period in the hospital.

    Device Description

    Not Found

    AI/ML Overview

    This is a letter acknowledging receipt of a 510(k) premarket notification for the PHOENIX Neonatal Phototherapy Unit CFL 101. It states the device is substantially equivalent to legally marketed predicate devices and can proceed to market. There is no information in the provided text about acceptance criteria or a study proving the device meets those criteria. The letter and associated forms are for administrative purposes related to FDA clearance, not for presenting performance data.

    Therefore, I cannot provide the requested information from the given text.

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