← Product Code [CCN](/submissions/AN/subpart-c%E2%80%94monitoring-devices/CCN) · K863613

# NO-FLO I (K863613)

_Design Technologies, Inc. · CCN · Dec 15, 1986 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CCN/K863613

## Device Facts

- **Applicant:** Design Technologies, Inc.
- **Product Code:** [CCN](/submissions/AN/subpart-c%E2%80%94monitoring-devices/CCN.md)
- **Decision Date:** Dec 15, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.2300
- **Device Class:** Class 1
- **Review Panel:** Anesthesiology

## Regulatory Identification

A bourdon gauge flowmeter is a device intended for medical purposes that is used in conjunction with respiratory equipment to sense gas pressure. The device is calibrated to indicate gas flow rate when the outflow is open to the atmosphere.

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CCN/K863613](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CCN/K863613)

**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