Device Classification Name |
chamber, hyperbaric
|
510(k) Number |
K001121 |
Device Name |
OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS) |
Applicant |
ENGINEERED MEDICAL TECHNOLOGY, INC. |
7303 HOUSTON HWY. |
P.O. BOX 1939 |
VICTORIA,
TX
77902
|
|
Applicant Contact |
DON SCHMIELEY |
Correspondent |
ENGINEERED MEDICAL TECHNOLOGY, INC. |
7303 HOUSTON HWY. |
P.O. BOX 1939 |
VICTORIA,
TX
77902
|
|
Correspondent Contact |
DON SCHMIELEY |
Regulation Number | 868.5470
|
Classification Product Code |
|
Date Received | 04/07/2000 |
Decision Date | 11/29/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|