[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: 21CFR882.1925]

[Page 417]
 
                        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. 882.1925  Ultrasonic scanner calibration test block.

    (a) Identification. An ultrasonic scanner calibration test block is 
a block of material with known properties used to calibrate ultrasonic 
scanning devices (e.g., the echoencephalograph).
    (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 the limitations in Sec. 882.9.

[44 FR 51730-51778, Sept. 4, 1979, as amended at 59 FR 63011, Dec. 7, 
1994; 66 FR 38807, July 25, 2001]