[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: 21CFR870.1120]

[Page 291-292]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 870--CARDIOVASCULAR DEVICES--Table of Contents
 
              Subpart B--Cardiovascular Diagnostic Devices
 
Sec. 870.1120  Blood pressure cuff.

    (a) Identification. A blood pressure cuff is a device that has an 
inflatable bladder in an inelastic sleeve (cuff) with a mechanism for 
inflating and deflating the bladder. The cuff is used in conjunction 
with another device to determine a subject's blood pressure.

[[Page 292]]

    (b) Classification. Class II (performance standards).