Empatica Health Monitoring Platform— 510(k) K221282

Substantially Equivalent

Empatica S.r.l.

FDA 510(k) clearance K221282 for Empatica Health Monitoring Platform, Substantially Equivalent on 2022-11-20. Applicant: Empatica S.r.l..

Clearance details

Applicant: Empatica S.r.l.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2022-05-03
Decision date: 2022-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milan, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.