Device Classification Name |
Ventilatory Effort Recorder
|
510(k) Number |
K131994 |
Device Name |
SOMNOLYZER 24X7 |
Applicant |
RESPIRONICS, INC. |
1740 GOLDEN MILE HIGHWAY |
MONROEVILLE,
PA
15146
|
|
Applicant Contact |
DANIELA AIZPITARTE |
Correspondent |
RESPIRONICS, INC. |
1740 GOLDEN MILE HIGHWAY |
MONROEVILLE,
PA
15146
|
|
Correspondent Contact |
DANIELA AIZPITARTE |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 06/28/2013 |
Decision Date | 10/17/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|