Device Classification Name |
Ventilatory Effort Recorder
|
510(k) Number |
K071556 |
Device Name |
SOMNOSCREEN EEG10-20 |
Applicant |
SOMNOMEDICS GMBH |
719 A STREET NE |
WASHINGTON,
DC
20002
|
|
Applicant Contact |
CHERITA JAMES |
Correspondent |
SOMNOMEDICS GMBH |
719 A STREET NE |
WASHINGTON,
DC
20002
|
|
Correspondent Contact |
CHERITA JAMES |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 06/07/2007 |
Decision Date | 07/18/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|