← Product Code [DSI](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI) · K802472

# BIOMETRIC ERG SYSTEM (K802472)

_Biometric Analysis Group, Inc. · DSI · Nov 26, 1980 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K802472

## Device Facts

- **Applicant:** Biometric Analysis Group, Inc.
- **Product Code:** [DSI](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI.md)
- **Decision Date:** Nov 26, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1025
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

## Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K802472](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K802472)

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