← Product Code [BZT](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZT) · K885347 # VITACOMM MODEL #140/141 ESOPHAGEAL STETHOSCOPE (K885347) _Vitacomm, Inc. · BZT · Jan 30, 1989 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZT/K885347 ## Device Facts - **Applicant:** Vitacomm, Inc. - **Product Code:** [BZT](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZT.md) - **Decision Date:** Jan 30, 1989 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.1920 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology ## Regulatory Identification An esophageal stethoscope with electrical conductors is a device that is inserted into the esophagus to listen to a patient's heart and breath sounds and to monitor electrophysiological signals. The device may also incorporate a thermistor for temperature measurement. --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZT/K885347](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZT/K885347) **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/AN/subpart-b%E2%80%94diagnostic-devices/BZT/K885347