Device Classification Name |
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
|
510(k) Number |
K230457 |
Device Name |
Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal |
Applicant |
Empatica S.r.l. |
Via Stendhal, 36 |
Milan,
IT
20144
|
|
Applicant Contact |
Alberto Poli |
Correspondent |
Empatica S.r.l. |
Via Stendhal, 36 |
Milan,
IT
20144
|
|
Correspondent Contact |
Alberto Poli |
Regulation Number | 870.2300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/21/2023 |
Decision Date | 10/30/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT04897529 NCT04964609 NCT05701761
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|