510(k) K121885— EARLYSENSE CENTRAL DISPLAY SYSTEM

Substantially Equivalent

Earlysense, Ltd.

Clearance details

Applicant: Earlysense, Ltd.
Product code: Code MSX
Advisory panel: Cardiovascular
Date received: 2012-06-28
Decision date: 2012-09-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Ramat-Gan, IL

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.