← Product Code [JOP](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP) · K870857

# ABCOM 1 CARDIAC OUTPUT MONITOR (K870857)

_Applied Biometrics, Inc. · JOP · Nov 16, 1987 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP/K870857

## Device Facts

- **Applicant:** Applied Biometrics, Inc.
- **Product Code:** [JOP](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP.md)
- **Decision Date:** Nov 16, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.2880
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

An ultrasonic transducer is a device applied to the skin to transmit and receive ultrasonic energy that is used in conjunction with an echocardiograph to provide imaging of cardiovascular structures. This device includes phased arrays and two-dimensional scanning transducers.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP/K870857](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOP/K870857)

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