PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101

• K Number: K040853
• Device Name: PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101
• Manufacturer: INTERNATIONAL HOSPITAL SUPPLY CO.
• Date Cleared: 2004-06-21 ( 81 days)
• Product Code: LBI
• Regulation Number: 880.5700
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

The PHOENIX Neonatal Phototherapy Unit CFL 101 provides light therapy for the treatment of hyperbilirubinemia, commonly light therapy for and jaundice, during the newborn period in the hospital.

Device Description

Not Found

AI/ML Overview

This is a letter acknowledging receipt of a 510(k) premarket notification for the PHOENIX Neonatal Phototherapy Unit CFL 101. It states the device is substantially equivalent to legally marketed predicate devices and can proceed to market. There is no information in the provided text about acceptance criteria or a study proving the device meets those criteria. The letter and associated forms are for administrative purposes related to FDA clearance, not for presenting performance data.

Therefore, I cannot provide the requested information from the given 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).