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510(k) Data Aggregation

K Number

Device Name

ULTRA BILI LIGHT

Manufacturer

PHYSICIAN ENGINEERED PRODUCTS, INC.

Date Cleared

1998-05-20

(147 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

ULTRA BILI LIGHT

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

The intended use of the portable Ultra Bili Light model 2000 is to provide Home Phototherapy treaturent for Neonatal Hyperbilirubinemia.

Device Description

Ultra Bili Light

AI/ML Overview

This document is a marketing authorization letter from the FDA for a medical device called "Ultra Bili Light." It does not contain information about acceptance criteria, study details, or performance data comparing AI to human readers. Therefore, I cannot fulfill your request based on the provided text.

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