Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5630](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5630) → NVO — Spacer, Direct Patient Interface

# NVO · Spacer, Direct Patient Interface

_Anesthesiology · 21 CFR 868.5630 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NVO

## Overview

- **Product Code:** NVO
- **Device Name:** Spacer, Direct Patient Interface
- **Regulation:** [21 CFR 868.5630](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5630)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K101532](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NVO/K101532.md) | NESSI OTC SPACER | Pharmacaribe | Sep 1, 2010 | SESE |
| [K091862](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NVO/K091862.md) | NESSI SPACER | Pharmacaribe | Nov 20, 2009 | SESE |

## Top Applicants

- Pharmacaribe — 2 clearances

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NVO](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/NVO)

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