Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K010925 |
Device Name |
SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E |
Applicant |
SIEMENS ELEMA AB |
MEDICAL SOLUTIONS |
186 WOOD AVENUE SOUTH |
ISELIN,
NJ
08830 -2770
|
|
Applicant Contact |
DIANE WURZBURGER |
Correspondent |
SIEMENS ELEMA AB |
MEDICAL SOLUTIONS |
186 WOOD AVENUE SOUTH |
ISELIN,
NJ
08830 -2770
|
|
Correspondent Contact |
DIANE WURZBURGER |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 03/27/2001 |
Decision Date | 12/18/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|