21 CFR 868.1150 — Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
Anesthesiology (AN) · Part 868 Subpart B—Diagnostic Devices · § 868.1150
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.
Classification Rationale
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.”
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CCC | Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling | 2 | 15 | 3rd Party |
Special Controls
CCC — Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
*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.”
eCFR
CCC — Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
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.”
Ecfr Llm
