GroundRules
21 CFR 868.1150: Indwelling blood carbon dioxide partial pressure (P2CO2) analyzer.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 868—ANESTHESIOLOGY DEVICES
- Subpart B—Diagnostic Devices
(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.”
Collected 2026-08-27T02:24:47Z. Source file · JSON