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K Number
K984589
Device Name
PHOTOTHERAPY LAMP
Manufacturer
MEDELA, INC.
Date Cleared
1999-04-20

(117 days)

Product Code
LBI
Regulation Number
880.5700
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis 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.

§ 880.5700 Neonatal phototherapy unit.

(a)
Identification. A neonatal phototherapy unit is a device used to treat or prevent hyperbilirubinemia (elevated serum bilirubin level). The device consists of one or more lamps that emit a specific spectral band of light, under which an infant is placed for therapy. This generic type of device may include supports for the patient and equipment and component parts.(b)
Classification. Class II (performance standards).