Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5710](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5710) → FNC — Tent, Pediatric Aerosol

# FNC · Tent, Pediatric Aerosol

_Anesthesiology · 21 CFR 868.5710 · Class 2_

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

## Overview

- **Product Code:** FNC
- **Device Name:** Tent, Pediatric Aerosol
- **Regulation:** [21 CFR 868.5710](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5710)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

An electrically powered oxygen tent is a device that encloses a patient's head and, by means of an electrically powered unit, administers breathing oxygen and controls the temperature and humidity of the breathing gases. This generic type device includes the pediatric aerosol tent.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K884922](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/FNC/K884922.md) | THE BREATHE EASE NURSERY VAPOR TENT | Cal-Trends Products | Feb 3, 1989 | SESE |

## Top Applicants

- Cal-Trends Products — 1 clearance

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

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