21 C.F.R. § 880.2400

Current through November 30, 2024
Section 880.2400 - Bed-patient monitor
(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 .

21 C.F.R. §880.2400

45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38803 , July 25, 2001