ULTRA BILI LIGHT

• K Number: K974830
• Device Name: ULTRA BILI LIGHT
• Manufacturer: PHYSICIAN ENGINEERED PRODUCTS, INC.
• Date Cleared: 1998-05-20 ( 147 days)
• Product Code: LBI
• Regulation Number: 880.5700
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

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.

Regulation Number and Section

§ 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).