← Product Code [BYK](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYK) · K882817

# LUNG DIFFUSION GAS MIXTURE (K882817)

_Swisco, Inc. · BYK · Aug 15, 1988 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYK/K882817

## Device Facts

- **Applicant:** Swisco, Inc.
- **Product Code:** [BYK](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYK.md)
- **Decision Date:** Aug 15, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5710
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYK/K882817](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYK/K882817)

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