[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR880.2700]

[Page 379]
 
                        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. 880.2700  Stand-on patient scale.

    (a) Identification. A stand-on patient scale is a device intended 
for medical purposes that is used to weigh a patient who is able to 
stand on the scale platform.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807. The 
device also is exempt from the good manufacturing practice regulation in 
part 820, with the exception of Sec. 820.180, with respect to general 
requirements concerning records, and Sec. 820.198, with respect to 
complaint files.