Device Classification Name |
Full-Montage Standard Electroencephalograph
|
510(k) Number |
K173460 |
Device Name |
NeuroEEG |
Applicant |
MemoryMD Inc. |
205 East 42nd St 14th FL |
New York,
NY
10017
|
|
Applicant Contact |
Abdus-Salaam Muwwakkil |
Correspondent |
MemoryMD Inc. |
205 East 42nd St 14th FL |
New York,
NY
10017
|
|
Correspondent Contact |
Abdus-Salaam Muwwakkil |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 11/07/2017 |
Decision Date | 02/16/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|