21 C.F.R. § 880.5140 Pediatric hospital bed.
Title 21 - Food and Drugs
(a) Identification. A pediatric hospital bed is a device intended for medical purposes that consists of a bed or crib designed for the use of a pediatric patient, with fixed end rails and movable and latchable side rails. The contour of the bed surface may be adjustable. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §880.9. [45 FR 69682–69737, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998]
Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart F—General Hospital and Personal Use Therapeutic Devices
§ 880.5140 Pediatric hospital bed.
