Device Classification Name |
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
|
510(k) Number |
K120450 |
Device Name |
SLEEP PROFILER |
Applicant |
ADVANCED BRAIN MONITORING, INC. |
W324 S3649 COUNTY RD E |
DOUSMAN,
WI
53118
|
|
Applicant Contact |
ADRIENNE LENZ |
Correspondent |
ADVANCED BRAIN MONITORING, INC. |
W324 S3649 COUNTY RD E |
DOUSMAN,
WI
53118
|
|
Correspondent Contact |
ADRIENNE LENZ |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 02/14/2012 |
Decision Date | 09/19/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|