21 C.F.R. § 880.2400 Bed-patient monitor.
Title 21 - Food and Drugs
(a) Identification. A bed-patient monitor is a battery-powered device placed under a mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §880.9. [45 FR 69682–69737, Oct. 21, 1980, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001]
Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart C—General Hospital and Personal Use Monitoring Devices
§ 880.2400 Bed-patient monitor.
