| Device Classification Name |
Analyzer, Gas, Oxygen, Gaseous-Phase
|
| 510(k) Number |
K890058 |
| Device Name |
VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM |
| Applicant |
| Vascular Technology Incorporated |
| 25 Industrial Ave. |
|
Chelmsford,
MA
01824
|
|
| Applicant Contact |
WILLIAM R OLIVER |
| Correspondent |
| Vascular Technology Incorporated |
| 25 Industrial Ave. |
|
Chelmsford,
MA
01824
|
|
| Correspondent Contact |
WILLIAM R OLIVER |
| Regulation Number | 868.1720 |
| Classification Product Code |
|
| Date Received | 01/06/1989 |
| Decision Date | 11/21/1989 |
| 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
|
|
|