← Product Code [DTC](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC) · K781349 # PACER-TRACER PULSE WIDTH (K781349) _Instromedix, Inc. · DTC · Aug 31, 1978 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K781349 ## Device Facts - **Applicant:** Instromedix, Inc. - **Product Code:** [DTC](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC.md) - **Decision Date:** Aug 31, 1978 - **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. --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K781349](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K781349) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTC/K781349