[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR882.1790]

[Page 416]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 882--NEUROLOGICAL DEVICES--Table of Contents
 
               Subpart B--Neurological Diagnostic Devices
 
Sec. 882.1790  Ocular plethysmograph.

    (a) Identification. An ocular plethysmograph is a device used to 
measure or detect volume changes in the eye produced by pulsations of 
the artery, to diagnose carotid artery occlusive disease (restrictions 
on blood flow in the carotid artery).
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 882.3.

[44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17739, May 11, 
1987]