← Product Code [BXY](/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXY) · K781523

# PFT GASES (K781523)

_Gardner Cryogenics · BXY · Dec 1, 1978 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXY/K781523

## Device Facts

- **Applicant:** Gardner Cryogenics
- **Product Code:** [BXY](/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXY.md)
- **Decision Date:** Dec 1, 1978
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.2350
- **Device Class:** Class 1
- **Review Panel:** Anesthesiology

## Regulatory Identification

A gas calibration flowmeter is a device intended for medical purposes that is used to calibrate flowmeters and accurately measure gas flow.

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXY/K781523](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/BXY/K781523)

**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