21 CFR 870.4410 — Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
Cardiovascular (CV) · Part 870 Subpart E—Cardiovascular Surgical Devices · § 870.4410
Identification
A cardiopulmonary bypass in-line blood gas sensor is a transducer that measures the level of gases in the blood.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DTY | Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass | 2 | 8 | 3rd Party |
