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.

Code of Federal Regulations

[45 FR 69682-69737, Oct. 21, 1980, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001]

CFR

880.2400—Bed-patient monitor.

Code of Federal Regulations