Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart C — Monitoring Devices](/submissions/AN/subpart-c%E2%80%94monitoring-devices) → [21 CFR 868.2380](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2380) → MRP — Analyzer, Nitric Oxide

# MRP · Analyzer, Nitric Oxide

_Anesthesiology · 21 CFR 868.2380 · Class 2_

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

## Overview

- **Product Code:** MRP
- **Device Name:** Analyzer, Nitric Oxide
- **Regulation:** [21 CFR 868.2380](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2380)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

The nitric oxide analyzer is a device intended to measure the concentration of nitric oxide in respiratory gas mixtures during administration of nitric oxide.

## Classification Rationale

Class II. The special control for this device is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.”

## Special Controls

The special control for this device is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.”

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K023014](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/MRP/K023014.md) | VIANOX DELIVERY SYSTEM, MODEL I | Pulmonox Medical, Inc. | Aug 14, 2003 | SESE |

## Top Applicants

- Pulmonox Medical, Inc. — 1 clearance

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

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