← Product Code [DRL](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRL) · K880780

# HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG (K880780)

_First Medical Devices Corp. · DRL · May 12, 1988 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRL/K880780

## Device Facts

- **Applicant:** First Medical Devices Corp.
- **Product Code:** [DRL](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRL.md)
- **Decision Date:** May 12, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.5325
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A defibrillator tester is a device that is connected to the output of a defibrillator and is used to measure the energy delivered by the defibrillator into a standard resistive load. Some testers also provide waveform information.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRL/K880780](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRL/K880780)

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