Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart C — Monitoring Devices](/submissions/AN/subpart-c%E2%80%94monitoring-devices) → [21 CFR 868.2025](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2025) → CBA — Monitor, Air Embolism, Ultrasonic

# CBA · Monitor, Air Embolism, Ultrasonic

_Anesthesiology · 21 CFR 868.2025 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CBA

## Overview

- **Product Code:** CBA
- **Device Name:** Monitor, Air Embolism, Ultrasonic
- **Regulation:** [21 CFR 868.2025](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2025)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)
- **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).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K780703](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CBA/K780703.md) | CUFF PACER | Omp Laboratories, Inc. | Jul 17, 1978 | SESE |

## Top Applicants

- Omp Laboratories, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CBA](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CBA)

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