21 CFR 868.2025 — Monitor, Air Embolism, Ultrasonic
Anesthesiology (AN) · Part 868 Subpart C—Monitoring Devices · § 868.2025
Identification
An ultrasonic air embolism monitor is a device used to detect air bubbles in a patient's blood stream. It may use Doppler or other ultrasonic principles.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CBA | Monitor, Air Embolism, Ultrasonic | 2 | 1 | 3rd Party |
