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Found 2 results

510(k) Data Aggregation

K Number

Device Name

PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE

Manufacturer

FISHER & PAYKEL HEALTHCARE, LTD.

Date Cleared

2000-09-25

(49 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

PHOTOTHERAPY LAMP

Manufacturer

Date Cleared

1999-04-20

(117 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Reference & Predicate Devices

N/A

Predicate For

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.

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