[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: 21CFR892.1410]

[Page 498]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 892--RADIOLOGY DEVICES--Table of Contents
 
                      Subpart B--Diagnostic Devices
 
Sec. 892.1410  Nuclear electrocardiograph synchronizer.

    (a) Identification. A nuclear electrocardiograph synchronizer is a 
device intended for use in nuclear radiology to relate the time of image 
formation to the cardiac cycle during the production of dynamic cardiac 
images.
    (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. 892.9.

[55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2322, Jan. 14, 2000]