21 CFR 868.1200
§ 868.1200 Indwelling blood oxygen partial pressure (P
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 868.1200, § 868.1200 Indwelling blood oxygen partial pressure (P, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89714
- Permanent ID
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Full text
(a) Identification. An indwelling blood oxygen partial pressure (PO2) analyzer is a device that consists of a catheter-tip PO2 transducer (e.g., PO2 electrode) and that is used to measure, in vivo, the partial pressure of oxygen in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status.
(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.