Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K871354 |
Device Name |
SERVO VENTILATOR 900 C/D |
Applicant |
SIEMENS ELEMA AB |
2360 NORTH PALMER DR. |
P.O. BOX 94517 |
SCHAUMBURG,
IL
60195
|
|
Applicant Contact |
ELLEN FARNEY |
Correspondent |
SIEMENS ELEMA AB |
2360 NORTH PALMER DR. |
P.O. BOX 94517 |
SCHAUMBURG,
IL
60195
|
|
Correspondent Contact |
ELLEN FARNEY |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 04/06/1987 |
Decision Date | 07/21/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|