Device Classification Name |
Reduced- Montage Standard Electroencephalograph
|
510(k) Number |
K152040 |
Device Name |
X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29) |
Applicant |
ADVANCED BRAIN MONITORING, INC. |
2237 FARADAY AVENUE, SUITE 100 |
CARLSBAD,
CA
92008
|
|
Applicant Contact |
DANIEL J. LEVENDOWSKI |
Correspondent |
PATHWAY REGULATORY CONSULTING, LLC |
W324S3649 COUNTY ROAD E |
DOUSMAN,
WI
53118
|
|
Correspondent Contact |
ADRIENNE LENZ |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/22/2015 |
Decision Date | 10/30/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|