| Device Classification Name |
Arterial Blood Sampling Kit
|
| 510(k) Number |
K925453 |
| Device Name |
SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT I |
| Applicant |
| Sherwood Medical Co. |
| 1915 Olive St. |
|
St. Louis,
MO
63103
|
|
| Applicant Contact |
DENNIS POZZO |
| Correspondent |
| Sherwood Medical Co. |
| 1915 Olive St. |
|
St. Louis,
MO
63103
|
|
| Correspondent Contact |
DENNIS POZZO |
| Regulation Number | 868.1100 |
| Classification Product Code |
|
| Date Received | 10/28/1992 |
| Decision Date | 07/12/1993 |
| Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|