PORTABLE LIQUID OXYGEN UNIT AND STATIONARY LIQUID OXYGEN UNIT
Device Facts
| Record ID | K963956 |
|---|---|
| Device Name | PORTABLE LIQUID OXYGEN UNIT AND STATIONARY LIQUID OXYGEN UNIT |
| Applicant | Southern Research, Inc. |
| Product Code | BYJ · Anesthesiology |
| Decision Date | Dec 9, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5655 |
| Device Class | Class 2 |
Regulatory Classification
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.
