EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0— 510(k) K100376

Name: FDA 510(k) clearance K100376
Creator: U.S. Food and Drug Administration
Published: 2010-08-06

Substantially Equivalent

Earlysense, Ltd.

FDA 510(k) clearance K100376 for EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0, Substantially Equivalent on 2010-08-06. Applicant: Earlysense, Ltd.. Device class: 2.

Clearance details

Applicant: Earlysense, Ltd.
Product code: Code MSX
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2010-02-12
Decision date: 2010-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ramat-Gan, IL

Download summary PDF View on FDA.gov ↗

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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.