Devices · Eko Health, Inc.

Eko Low Ejection Fraction Tool (ELEFT)

Eko Health, Inc. is listed for Eko Low Ejection Fraction Tool (ELEFT) (K233409). The FDA list gives March 28, 2024 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QYE as “Reduced Ejection Fraction Machine Learning-Based Notification Software”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K233409

Official FDA database record

Date of final decision

March 28, 2024

Company on the FDA list

Eko Health, Inc.

Lead panel

Cardiovascular

Primary product code

QYE

openFDA device name for the code

Reduced Ejection Fraction Machine Learning-Based Notification Software

Device class

2

Regulation number

870.2380

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary