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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2014]
[CITE: 21CFR880.5140]
See Related Information on Pediatric hospital bed. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 880 -- GENERAL HOSPITAL AND PERSONAL USE DEVICES

Subpart F--General Hospital and Personal Use Therapeutic Devices

Sec. 880.5140 Pediatric hospital bed.

(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, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998]

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