21 CFR 868.1170
§ 868.1170 Indwelling blood hydrogen ion concentration (pH) analyzer.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 868.1170, § 868.1170 Indwelling blood hydrogen ion concentration (pH) analyzer, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89713
- Permanent ID
ys:prov:89713@1- SHA-256
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Full text
(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.”
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.