Device Classification Name |
Full-Montage Standard Electroencephalograph
|
510(k) Number |
K171384 |
Device Name |
Micromed BRAIN QUICK system |
Applicant |
Micromed S.P.A |
Via Giotto 2 |
Mogliano Veneto,
IT
31021
|
|
Applicant Contact |
Monica Camillo |
Correspondent |
EAS Consulting Group |
1700 Diagonal Road Suite 750 |
Alexandria,
VA
22314
|
|
Correspondent Contact |
J. P. Ouellette |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/11/2017 |
Decision Date | 02/01/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|