← Product Code [BZO](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZO) · K863910

# RAINCOAT (K863910)

_Artec Environmental Monitoring Division · BZO · Oct 20, 1986 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZO/K863910

## Device Facts

- **Applicant:** Artec Environmental Monitoring Division
- **Product Code:** [BZO](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZO.md)
- **Decision Date:** Oct 20, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5975
- **Device Class:** Class 1
- **Review Panel:** Anesthesiology

## Regulatory Identification

Ventilator tubing is a device intended for use as a conduit for gases between a ventilator and a patient during ventilation of the patient.

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZO/K863910](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZO/K863910)

**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
