Device Classification Name |
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
|
510(k) Number |
K162140 |
Device Name |
RemLogic |
Applicant |
EMBLA SYSTEMS |
1 HINES ROAD SUITE 202 |
KANATA,
CA
K2K 3C7
|
|
Applicant Contact |
SHANE T. SAWALL |
Correspondent |
EMBLA SYSTEMS |
1 HINES ROAD SUITE 202 |
KANATA,
CA
K2K 3C7
|
|
Correspondent Contact |
SHANE T. SAWALL |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 08/01/2016 |
Decision Date | 12/01/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|