← Product Code [CCQ](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ) · K853350

# SYNCHRONER TM (PROPOSED TRADENAME) (K853350)

_Fisons Corp. · CCQ · Aug 29, 1985 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K853350

## Device Facts

- **Applicant:** Fisons Corp.
- **Product Code:** [CCQ](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ.md)
- **Decision Date:** Aug 29, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5640
- **Device Class:** Class 1
- **Review Panel:** Anesthesiology

## Regulatory Identification

A medicinal nonventilatory nebulizer (atomizer) is a device that is intended to spray liquid medication in aerosol form into the air that a patient will breathe.

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K853350](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CCQ/K853350)

**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
