[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: 21CFR882.1500]

[Page 414-415]
 
                        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. 882.1500  Esthesiometer.

    (a) Identification. An esthesiometer is a mechanical device which 
usually consists of a single rod or fiber which is held in the fingers 
of the physician or other examiner and which is used to determine 
whether a patient has tactile sensitivity.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter

[[Page 415]]

subject to Sec. 882.9. The device is also exempt from the current good 
manufacturing practice regulations in part 820 of this chapter, with the 
exception of Sec. 820.180 of this chapter, with respect to general 
requirements concerning records, and Sec. 820.198 of this chapter, with 
respect to complaint files.

[44 FR 51730-51778, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 
1989; 65 FR 2319, Jan. 14, 2000]