Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K091112 |
Device Name |
RESPIRONICS SLEEPEASY CPAP SYSTEM |
Applicant |
RESPIRONICS, INC. |
1740 GOLDEN MILE HIGHWAY |
MONROEVILLE,
PA
15146
|
|
Applicant Contact |
ZITA A YURKO |
Correspondent |
RESPIRONICS, INC. |
1740 GOLDEN MILE HIGHWAY |
MONROEVILLE,
PA
15146
|
|
Correspondent Contact |
ZITA A YURKO |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 04/17/2009 |
Decision Date | 05/15/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|