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EVERON CENTRAL DISPLAY STATION (CDS)

K110521 Class II Special
Decision Date
2011-04-19
Sponsor / Applicant
Earlysense, Ltd.

Technical Specification

510(k) Submission ID K110521
Product Code MSX
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.2300
Decision Date 2011-04-19
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

EVERON CENTRAL DISPLAY STATION (CDS) received FDA 510(k) clearance under submission number K110521, sponsored by Earlysense, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2011-04-19.

Classification & Regulation

This clearance is catalogued under FDA product code MSX and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.