Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal— 510(k) K230457

Substantially Equivalent

Empatica S.r.l.

FDA 510(k) clearance K230457 for Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal, Substantially Equivalent on 2023-10-30. Applicant: Empatica S.r.l..

Clearance details

Applicant: Empatica S.r.l.
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2023-02-21
Decision date: 2023-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milan, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.