← Product Code [CCK](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK) · K863883

# MODELS 4002/4102/4202 OXY. DELIVERY/CO2 CANNULA (K863883)

_Salter Labs · CCK · Oct 27, 1986 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK/K863883

## Device Facts

- **Applicant:** Salter Labs
- **Product Code:** [CCK](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK.md)
- **Decision Date:** Oct 27, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.1400
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK/K863883](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK/K863883)

**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
