← Product Code [BYJ](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYJ) · K863978

# PORTABLE LIQUID OXYGEN UNIT (MODIFICATION) (K863978)

_Penox Technologies, Inc. · BYJ · Dec 15, 1986 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYJ/K863978

## Device Facts

- **Applicant:** Penox Technologies, Inc.
- **Product Code:** [BYJ](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYJ.md)
- **Decision Date:** Dec 15, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5655
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

A portable liquid oxygen unit is a portable, thermally insulated container of liquid oxygen that is intended to supplement gases to be inhaled by a patient, is sometimes accompanied by tubing and an oxygen mask. An empty portable liquid oxygen unit is a device, while the oxygen contained therein is a drug.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYJ/K863978](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYJ/K863978)

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