← Product Code [DRI](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRI) · K822316

# HEART MONITOR BRACELET ALARM (K822316)

_Hmba · DRI · Sep 21, 1982 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRI/K822316

## Device Facts

- **Applicant:** Hmba
- **Product Code:** [DRI](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRI.md)
- **Decision Date:** Sep 21, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.2620
- **Device Class:** Class 1
- **Review Panel:** Cardiovascular

## Regulatory Identification

A line isolation monitor is a device used to monitor the electrical leakage current from a power supply electrically isolated from the commercial power supply received from a utility company.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRI/K822316](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRI/K822316)

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