[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: 21CFR880.5420]

[Page 389-390]
 
                        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 F--General Hospital and Personal Use Therapeutic Devices
 
Sec. 880.5420  Pressure infusor for an I.V. bag.

    (a) Identification. A pressure infusor for an I.V. bag is a device 
consisting of an inflatable cuff which is placed around an I.V. bag. 
When the device is inflated, it increases the pressure on the I.V. bag 
to assist the infusion of the fluid.

[[Page 390]]

    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 880.9.

[45 FR 69682-69737, Oct. 21, 1980, as amended at 65 FR 2318, Jan. 14, 
2000]