Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K093416 |
Device Name |
TRILOGY 200 VENTILATOR |
Applicant |
RESPIRONICS, INC. |
1740 GOLDEN MILE HIGHWAY |
MONROEVILLE,
PA
15146
|
|
Applicant Contact |
ZITA YURKO |
Correspondent |
RESPIRONICS, INC. |
1740 GOLDEN MILE HIGHWAY |
MONROEVILLE,
PA
15146
|
|
Correspondent Contact |
ZITA YURKO |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 11/02/2009 |
Decision Date | 01/29/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|