[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR868.1170]

[Page 296]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 868_ANESTHESIOLOGY DEVICES--Table of Contents
 
                      Subpart B_Diagnostic Devices
 
Sec. 868.1170  Indwelling blood hydrogen ion concentration (pH) analyzer.

    (a) Identification. An indwelling blood hydrogen ion concentration 
(pH) analyzer is a device that consists of a catheter-tip pH electrode 
and that is used to measure, in vivo, the hydrogen ion concentration 
(pH) in blood to aid in determining the patient's acid-base balance.
    (b) Classification. Class II (special controls). The special control 
for this device is FDA's ``Class II Special Controls Guidance Document: 
Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.''

[47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987; 66 
FR 57368, Nov. 15, 2001]