[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: 21CFR876.5665]

[Page 357]
 
                        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 F--Therapeutic Devices
 
Sec. 876.5665  Water purification system for hemodialysis.

    (a) Identification. A water purification system for hemodialysis is 
a device that is intended for use with a hemodialysis system and that is 
intended to remove organic and inorganic substances and microbial 
contaminants from water used to dilute dialysate concentrate to form 
dialysate. This generic type of device may include a water softener, 
sediment filter, carbon filter, and water distillation system.
    (b) Classification. Class II (performance standards).