← Product Code [DTC](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC) · K901332

# PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE (K901332)

_Biotronik, GmbH & Co. · DTC · May 9, 1990 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K901332

## Device Facts

- **Applicant:** Biotronik, GmbH & Co.
- **Product Code:** [DTC](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC.md)
- **Decision Date:** May 9, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.3630
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A pacemaker generator function analyzer is a device that is connected to a pacemaker pulse generator to test any or all of the generator's parameters, including pulse duration, pulse amplitude, pulse rate, and sensing threshold.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K901332](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K901332)

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