Monitor, Air Embolism, Ultrasonic
The Ultrasonic Air Embolism Monitor is an anesthesiology device that uses ultrasound technology to detect the presence of air bubbles in a patient's bloodstream or vascular system during surgical procedures, providing early warning of potentially life-threatening air embolism. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CBA, regulated under 21 CFR 868.2025, within the Anesthesiology medical specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- CBA
- Device Class
- FDA class 2
- Regulation Number
- 868.2025
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K780703 | CUFF PACER | Jul 17, 1978 | Substantially Equivalent | Omp Laboratories, Inc. |