| Device Classification Name |
Calculator, Predicted Values, Pulmonary Function
|
| 510(k) Number |
K932744 |
| Device Name |
FLOWSCREEN |
| Applicant |
| Erich Jaeger, Inc. |
| P.O. Box 10008 |
|
Rockford,
IL
61131
|
|
| Applicant Contact |
EICHLER |
| Correspondent |
| Erich Jaeger, Inc. |
| P.O. Box 10008 |
|
Rockford,
IL
61131
|
|
| Correspondent Contact |
EICHLER |
| Regulation Number | 868.1890 |
| Classification Product Code |
|
| Date Received | 06/08/1993 |
| Decision Date | 03/07/1994 |
| 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
|
|
|