| Device Classification Name |
Ventilator, Continuous, Facility Use
|
| 510(k) Number |
K902859 |
| Device Name |
SERVO VENTILATOR 300 |
| Applicant |
| Siemens Life Support Systems |
| 2360 N. Palmer Dr. |
|
Schaumburg,
IL
60173
|
|
| Applicant Contact |
ELLEN FARNEY |
| Correspondent |
| Siemens Life Support Systems |
| 2360 N. Palmer Dr. |
|
Schaumburg,
IL
60173
|
|
| Correspondent Contact |
ELLEN FARNEY |
| Regulation Number | 868.5895 |
| Classification Product Code |
|
| Date Received | 06/29/1990 |
| Decision Date | 04/26/1991 |
| 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
|
| Recalls |
CDRH Recalls
|
|
|