§ 880.2400. Bed-patient monitor.
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/us/cfr/t21/s§ 880.2400·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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, Oct. 21, 1980, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001]