Device Classification Name |
Ventilatory Effort Recorder
|
510(k) Number |
K081485 |
Device Name |
SOMNOWATCH |
Applicant |
SOMNOMEDICS GMBH |
901 KING STREET |
SUITE 200 |
ALEXANDRIA,
VA
22314
|
|
Applicant Contact |
CHERITA JAMES |
Correspondent |
SOMNOMEDICS GMBH |
901 KING STREET |
SUITE 200 |
ALEXANDRIA,
VA
22314
|
|
Correspondent Contact |
CHERITA JAMES |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 05/28/2008 |
Decision Date | 09/18/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|