| Device Classification Name |
Regulator, Pressure, Gas Cylinder
|
| 510(k) Number |
K891771 |
| Device Name |
VICTOR MEDICAL OXYGEN THERAPY REGULATOR, MODIFIED |
| Applicant |
| Thermadyne Holings Corp. |
| P.O. Drawer 1007 |
|
Denton,
TX
76202
|
|
| Applicant Contact |
W. F POPPE |
| Correspondent |
| Thermadyne Holings Corp. |
| P.O. Drawer 1007 |
|
Denton,
TX
76202
|
|
| Correspondent Contact |
W. F POPPE |
| Regulation Number | 868.2700 |
| Classification Product Code |
|
| Date Received | 03/24/1989 |
| Decision Date | 06/23/1989 |
| 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
|
|
|