21 CFR 868.1150
§ 868.1150 Indwelling blood carbon dioxide partial pressure (P
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 868.1150, § 868.1150 Indwelling blood carbon dioxide partial pressure (P, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89712
- Permanent ID
ys:prov:89712@1- SHA-256
7a4c49b574676489910a318a0e0d3d419608d25f8628bb22c753bc0822ae955c
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(a) Identification. An indwelling blood carbon dioxide partial pressure PCO2 analyzer is a device that consists of a catheter-tip PCO2 transducer (e.g., PCO2 electrode) and that is used to measure, in vivo, the partial pressure of carbon dioxide 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.