[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: 21CFR876.1800]

[Page 354]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES--Table of Contents
 
                      Subpart B--Diagnostic Devices
 
Sec. 876.1800  Urine flow or volume measuring system.

    (a) Identification. A urine flow or volume measuring system is a 
device that measures directly or indirectly the volume or flow of urine 
from a patient, either during the course of normal urination or while 
the patient is catheterized. The device may include a drip chamber to 
reduce the risk of retrograde bacterial contamination of the bladder and 
a transducer and electrical signal conditioning and display equipment. 
This generic type of device includes the electrical urinometer, 
mechanical urinometer, nonelectric urinometer, disposable nonelectric 
urine flow rate measuring device, and uroflowmeter.
    (b) Classification. (1) Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 63 
FR 59228, Nov. 3, 1998]