← Product Code [CCL](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCL) · K833496

# OXYGEN MONITOR/CONTROLLER (K833496)

_Oxequip Health Ind. · CCL · Dec 16, 1983 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCL/K833496

## Device Facts

- **Applicant:** Oxequip Health Ind.
- **Product Code:** [CCL](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCL.md)
- **Decision Date:** Dec 16, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.1720
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCL/K833496](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCL/K833496)

**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
