[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: 21CFR882.1825]

[Page 399-400]
 
                        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. 882.1825  Rheoencephalograph.

    (a) Identification. A rheoencephalograph is a device used to 
estimate a patient's cerebral circulation (blood flow in the brain) by 
electrical impedance methods with direct electrical connections to the 
scalp or neck area.
    (b) Classification. Class III (premarket approval).
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any 
rheoencephalograph that was

[[Page 400]]

in commercial distribution before May 28, 1976, or that has, on or 
before December 26, 1996 been found to be substantially equivalent to a 
rheoencephalograph that was in commercial distribution before May 28, 
1976. Any other rheoencephalograph shall have an approved PMA or a 
declared completed PDP in effect before being placed in commercial 
distribution.

[44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 
1987; 61 FR 50708, Sept. 27, 1996]