Device Classification Name |
physiological signal based seizure monitoring system
|
510(k) Number |
K181861 |
Device Name |
Embrace |
Applicant |
Empatica Srl |
Via Stendhal 36 |
milano,
IT
20144
|
|
Applicant Contact |
simone tognetti |
Correspondent |
Rakesh Lal |
318 Rindge Ave 407 |
cambridge,
MA
02140
|
|
Correspondent Contact |
rakesh lal |
Regulation Number | 882.1580
|
Classification Product Code |
|
Date Received | 07/12/2018 |
Decision Date | 12/20/2018 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
summary |
summary
|
Type |
Traditional
|
Clinical Trials |
NCT03207685
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|