← Product Code [DRR](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRR) · K771976

# ECG AMPLIFIER/R WAVE TRIGGER (K771976)

_G.D. Searle and Co. · DRR · Nov 9, 1977 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRR/K771976

## Device Facts

- **Applicant:** G.D. Searle and Co.
- **Product Code:** [DRR](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRR.md)
- **Decision Date:** Nov 9, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.2050
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A biopotential amplifier and signal conditioner is a device used to amplify or condition an electrical signal of biologic origin.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRR/K771976](https://fda.innolitics.com/submissions/RA/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRR/K771976)

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