[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: 21CFR880.2740]

[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. 880.2740  Surgical sponge scale.

    (a) Identification. A surgical sponge scale is a nonelectrically 
powered device used to weigh surgical sponges that have been used to 
absorb blood during surgery so that, by comparison with the known dry 
weight of the sponges, an estimate may be made of the blood lost by the 
patient during surgery.
    (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.