CBA · Monitor, Air Embolism, Ultrasonic
Anesthesiology · 21 CFR 868.2025 · Class 2
Overview
| Product Code | CBA |
|---|---|
| Device Name | Monitor, Air Embolism, Ultrasonic |
| Regulation | 21 CFR 868.2025 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
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).
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K780703 | CUFF PACER | Omp Laboratories, Inc. | Jul 17, 1978 | SESE |
Top Applicants
- Omp Laboratories, Inc. — 1 clearance
