21 CFR 870.4330 — Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Cardiovascular (CV) · Part 870 Subpart E—Cardiovascular Surgical Devices · § 870.4330
Identification
A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 | 47 | 3rd Party |
