| Device Classification Name |
Arterial Blood Sampling Kit
|
| 510(k) Number |
K843360 |
| Device Name |
ARTAP ARTERIAL BLOOD SAMPLING DEVICE |
| Applicant |
| Analytical Products, Inc. |
| 511 Taylor Way |
|
Belmont ,
CA
94002
|
|
| Applicant Contact |
BERRY DODD |
| Correspondent |
| Analytical Products, Inc. |
| 511 Taylor Way |
|
Belmont ,
CA
94002
|
|
| Correspondent Contact |
BERRY DODD |
| Regulation Number | 868.1100 |
| Classification Product Code |
|
| Date Received | 08/28/1984 |
| Decision Date | 10/31/1984 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Hematology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|