← Product Code [BYG](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG) · K852624

# OXY-TWO (K852624)

_Ashai Co. , Ltd. · BYG · Sep 18, 1985 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG/K852624

## Device Facts

- **Applicant:** Ashai Co. , Ltd.
- **Product Code:** [BYG](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG.md)
- **Decision Date:** Sep 18, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5580
- **Device Class:** Class 1
- **Review Panel:** Anesthesiology

## Regulatory Identification

An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG/K852624](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYG/K852624)

**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