| Device Classification Name |
Analyzer, Gas, Oxygen, Gaseous-Phase
|
| 510(k) Number |
K843847 |
| Device Name |
O2 TEST |
| Applicant |
| Erich Jaeger, Inc. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Applicant Contact |
RONALD EVEN |
| Correspondent |
| Erich Jaeger, Inc. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Correspondent Contact |
RONALD EVEN |
| Regulation Number | 868.1720 |
| Classification Product Code |
|
| Date Received | 10/01/1984 |
| Decision Date | 10/12/1984 |
| 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
|
|
|