21 C.F.R. § 880.5700 Neonatal phototherapy unit.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart F—General Hospital and Personal Use Therapeutic Devices
§ 880.5700 Neonatal phototherapy unit.
