Cleared Traditional

Eko Low Ejection Fraction Tool (ELEFT)

K233409 · Eko Health, Inc. · Cardiovascular
Mar 2024
Decision
174d
Days
Class 2
Risk

About This 510(k) Submission

K233409 is an FDA 510(k) clearance for the Eko Low Ejection Fraction Tool (ELEFT), a Reduced Ejection Fraction Machine Learning-based Notification Software (Class II — Special Controls, product code QYE), submitted by Eko Health, Inc. (Emeryville, US). The FDA issued a Cleared decision on March 28, 2024, 174 days after receiving the submission on October 6, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2380.

Submission Details

510(k) Number K233409 FDA.gov
FDA Decision Cleared SESE
Date Received October 06, 2023
Decision Date March 28, 2024
Days to Decision 174 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code QYE — Reduced Ejection Fraction Machine Learning-based Notification Software
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2380
Definition Reduced Ejection Fraction Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of A Reduced Ejection Fraction For Further Referral Or Diagnostic Follow-up.