21 C.F.R. § 868.1170 Indwelling blood hydrogen ion concentration (pH) analyzer.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES
Subpart B—Diagnostic Devices
§ 868.1170 Indwelling blood hydrogen ion concentration (pH) analyzer.
