| Device Classification Name |
Unit, Liquid-Oxygen, Portable
|
| 510(k) Number |
K880183 |
| Device Name |
PORTABLE THERAPEUTIC LIQUID OXYGEN UNIT |
| Applicant |
| Essex Cryogenics of Missouri, Inc. |
| 8007 Chivvis Dr. |
|
St. Louis,
MO
63123
|
|
| Applicant Contact |
FRED SNYDER |
| Correspondent |
| Essex Cryogenics of Missouri, Inc. |
| 8007 Chivvis Dr. |
|
St. Louis,
MO
63123
|
|
| Correspondent Contact |
FRED SNYDER |
| Regulation Number | 868.5655 |
| Classification Product Code |
|
| Date Received | 01/15/1988 |
| Decision Date | 04/14/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|