Device Classification Name |
standard polysomnograph with electroencephalograph
|
510(k) Number |
K012085 |
Device Name |
SOMNO STAR & SERIES SLEEP SYSTEM |
Applicant |
SENSORMEDICS CORP. |
22705 SAVI RANCH PKWY. |
YORBA LINDA,
CA
92887 -4645
|
|
Applicant Contact |
LINDA MURDOCK |
Correspondent |
SENSORMEDICS CORP. |
22705 SAVI RANCH PKWY. |
YORBA LINDA,
CA
92887 -4645
|
|
Correspondent Contact |
LINDA MURDOCK |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 07/03/2001 |
Decision Date | 08/02/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|