← Product Code [BYR](/submissions/AN/subpart-c%E2%80%94monitoring-devices/BYR) · K896718

# BICORE VARIFLEX(R) FLOW TRANSDUCER (K896718)

_Bicore Monitoring Systems · BYR · Feb 22, 1990 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BYR/K896718

## Device Facts

- **Applicant:** Bicore Monitoring Systems
- **Product Code:** [BYR](/submissions/AN/subpart-c%E2%80%94monitoring-devices/BYR.md)
- **Decision Date:** Feb 22, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.2875
- **Device Class:** Class 1
- **Review Panel:** Anesthesiology

## Regulatory Identification

A differential pressure transducer is a two-chambered device intended for medical purposes that is often used during pulmonary function testing. It generates an electrical signal for subsequent display or processing that is proportional to the difference in gas pressures in the two chambers.

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BYR/K896718](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BYR/K896718)

**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:** Innolitics at https://innolitics.com
