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510(k) Data Aggregation

    K Number
    K002414

    Validate with FDA (Live)

    Device Name
    PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Date Cleared
    2000-09-25

    (49 days)

    Product Code
    LBI
    Regulation Number
    880.5700
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K984589

    Validate with FDA (Live)

    Device Name
    PHOTOTHERAPY LAMP
    Manufacturer
    MEDELA, INC.
    Date Cleared
    1999-04-20

    (117 days)

    Product Code
    LBI
    Regulation Number
    880.5700
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    K072097
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Medela's phototherapy lamp is intended for the treatment of excessive serumbilirubin concentrations in newborn babies.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry but this document does not contain the requested information. This document is a 510(k) clearance letter from the FDA for a phototherapy lamp and does not contain details about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

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