← Product Code [DTA](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTA) · K812104

# SIEMENS-ELEMA PSA 376 (K812104)

_Siemens Corp. · DTA · Dec 2, 1981 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTA/K812104

## Device Facts

- **Applicant:** Siemens Corp.
- **Product Code:** [DTA](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTA.md)
- **Decision Date:** Dec 2, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.3720
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A pacemaker electrode function tester is a device which is connected to an implanted pacemaker lead that supplies an accurately calibrated, variable pacing pulse for measuring the patient's pacing threshold and intracardiac R-wave potential.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTA/K812104](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTA/K812104)

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