[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR880.2400]

[Page 384]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES--Table of Contents
 
     Subpart C--General Hospital and Personal Use Monitoring Devices
 
Sec. 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 Sec. 880.9.

[45 FR 69682-69737, Oct. 21, l980, as amended at 59 FR 63010, Dec. 7, 
1994; 66 FR 38803, July 25, 2001]