[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR874.1070]

[Page 340]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 874--EAR, NOSE, AND THROAT DEVICES--Table of Contents
 
                      Subpart B--Diagnostic Devices
 
Sec. 874.1070  Short increment sensitivity index (SISI) adapter.

    (a) Identification. A short increment sensitivity index (SISI) 
adapter is a device used with an audiometer in diagnostic hearing 
evaluations. A SISI adapter provides short periodic sound pulses in 
specific small decibel increments that are intended to be superimposed 
on the audiometer's output tone frequency.
    (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. 874.9.

[55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2315, Jan. 14, 2000]