← Product Code [CCJ](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ) · K760169

# DIFFUSION SYSTEM, SINGLE-BREATH (47404A) (K760169)

_Hewlett-Packard Co. · CCJ · Jul 20, 1976 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K760169

## Device Facts

- **Applicant:** Hewlett-Packard Co.
- **Product Code:** [CCJ](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ.md)
- **Decision Date:** Jul 20, 1976
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.1430
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

A carbon monoxide gas analyzer is a device intended to measure the concentration of carbon monoxide in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as infrared absorption or gas chromatography.

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K760169](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCJ/K760169)

**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