[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: 21CFR890.1175]

[Page 498]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 890--PHYSICAL MEDICINE DEVICES--Table of Contents
 
             Subpart B--Physical Medicine Diagnostic Devices
 
Sec. 890.1175  Electrode cable.


    (a) Identification. An electrode cable is a device composed of 
strands of insulated electrical conductors laid together around a 
central core and intended for medical purposes to connect an electrode 
from a patient to a diagnostic machine.
    (b) Classification. Class II (special controls). The special 
controls consist of:
    (1) The performance standard under part 898 of this chapter, and
    (2) The guidance document entitled ``Guidance on the Performance 
Standard for Electrode Lead Wires and Patient Cables.'' This device is 
exempt from the premarket notification procedures of subpart E of part 
807 of this chapter subject to Sec. 890.9.

[48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994; 65 
FR 19319, Apr. 11, 2000]