← Product Code [BTC](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTC) · K822216

# VOLUMETRIC CONTROLLER (K822216)

_Quest Medical, Inc. · BTC · Aug 16, 1982 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTC/K822216

## Device Facts

- **Applicant:** Quest Medical, Inc.
- **Product Code:** [BTC](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTC.md)
- **Decision Date:** Aug 16, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5320
- **Device Class:** Class 1
- **Review Panel:** Anesthesiology

## Regulatory Identification

A reservoir bag is a device, usually made of conductive rubber, intended for use in a breathing circuit as a reservoir for breathing gas and to assist, control, or monitor a patient's ventilation.

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTC/K822216](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTC/K822216)

**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
