← Product Code [BZR](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR) · K960359

# ALADDIN MONITORING OXYGEN/AIR MIXER (K960359)

_Hamilton Medical, Inc. · BZR · Apr 24, 1996 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR/K960359

## Device Facts

- **Applicant:** Hamilton Medical, Inc.
- **Product Code:** [BZR](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR.md)
- **Decision Date:** Apr 24, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5330
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR/K960359](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZR/K960359)

**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
