Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart B — Diagnostic Devices](/submissions/AN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 868.1690](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1690) → CCI — Analyzer, Gas, Nitrogen, Gaseous-Phase

# CCI · Analyzer, Gas, Nitrogen, Gaseous-Phase

_Anesthesiology · 21 CFR 868.1690 · Class 2_

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

## Overview

- **Product Code:** CCI
- **Device Name:** Analyzer, Gas, Nitrogen, Gaseous-Phase
- **Regulation:** [21 CFR 868.1690](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1690)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)
- **3rd-party reviewable:** yes

## Identification

A nitrogen gas analyzer is a device intended to measure the concentration of nitrogen in respiratory gases to aid in determining a patient's ventilatory status. The device may use techniques such as gas chromatography or mass spectrometry.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K872024](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCI/K872024.md) | CO2/02 MONITOR MULTINEX | Datascope Corp. | Mar 31, 1988 | SESE |
| [K771516](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCI/K771516.md) | CAPILLARY SAMPLE LINE | Mcgaw Respiratory Therapy | Aug 16, 1977 | SESE |

## Top Applicants

- Datascope Corp. — 1 clearance
- Mcgaw Respiratory Therapy — 1 clearance

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

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