← Product Code [CCK](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK) · K010795

# CAPNOPROBE SL, MODEL 2000 (K010795)

_Optical Sensors, Inc. · CCK · Apr 11, 2001 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK/K010795

## Device Facts

- **Applicant:** Optical Sensors, Inc.
- **Product Code:** [CCK](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK.md)
- **Decision Date:** Apr 11, 2001
- **Decision:** SESE
- **Submission Type:** Special
- **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/K010795](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK/K010795)

**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