BETTERCARE PLATFORM - ADVANCED WEB CLIENT— 510(k) K171361

Substantially Equivalent

Better Care S.L.

FDA 510(k) clearance K171361 for BETTERCARE PLATFORM - ADVANCED WEB CLIENT, Substantially Equivalent on 2018-02-05. Applicant: Better Care S.L..

Clearance details

Applicant: Better Care S.L.
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2017-05-09
Decision date: 2018-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sabadell, ES

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.