| Device Classification Name |
Analyzer, Gas, Oxygen, Gaseous-Phase
|
| 510(k) Number |
K863806 |
| Device Name |
MODEL A-1 OXYGEN ANALYZER |
| Applicant |
| Medical, Inc. |
| 6570 Arapaho Dr. |
|
Evergreen,
CO
80439
|
|
| Applicant Contact |
JOHN PORTER |
| Correspondent |
| Medical, Inc. |
| 6570 Arapaho Dr. |
|
Evergreen,
CO
80439
|
|
| Correspondent Contact |
JOHN PORTER |
| Regulation Number | 868.1720 |
| Classification Product Code |
|
| Date Received | 09/30/1986 |
| Decision Date | 10/15/1986 |
| 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
|
|
|