§ 868.1170. Indwelling blood hydrogen ion concentration (pH) analyzer.
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/us/cfr/t21/s§ 868.1170·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]
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§ 868.1170
Indwelling blood hydrogen ion concentration (pH) analyzer.
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