EVERON CENTRAL DISPLAY STATION (CDS)— 510(k) K110521

Substantially Equivalent

Earlysense, Ltd.

FDA 510(k) clearance K110521 for EVERON CENTRAL DISPLAY STATION (CDS), Substantially Equivalent on 2011-04-19. Applicant: Earlysense, Ltd..

Clearance details

Applicant: Earlysense, Ltd.
Product code: Code MSX
Advisory panel: Cardiovascular
Date received: 2011-02-23
Decision date: 2011-04-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Ramat-Gan, IL

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Adverse events under product code MSX

product code MSX

Death: 59
Total: 59

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.