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ELEFT (Eko Low Ejection Fraction Tool)

FDA UDI

Class II (US FDA UDI)

by Eko Devices, Inc.

Identity

Trade Name
ELEFT (Eko Low Ejection Fraction Tool) FDA UDI
Generic Name
Cardiopulmonary physiological parameter analysis software FDA UDI
Device Name
Eko Low Ejection Fraction Tool (ELEFT) is a software intended to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. ELEFT takes as input ECG and heart sounds and is intended for use on patients at risk for heart failure. This population includes, but is not limited to, patients with: coronary artery disease; diabetes mellitus; cardiomyopathy; hypertension; and obesity. FDA UDI
Model / Reference
v7.x FDA UDI
Description
Eko Low Ejection Fraction Tool (ELEFT) is a software intended to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. ELEFT takes as input ECG and heart sounds and is intended for use on patients at risk for heart failure. This population includes, but is not limited to, patients with: coronary artery disease; diabetes mellitus; cardiomyopathy; hypertension; and obesity. FDA UDI

Identifiers

Catalog Number
ELEFT FDA UDI
Primary DI / UDI-DI
00850010298146 FDA UDI
510(k) Number
K233409 FDA UDI
FDA Product Code
QYE FDA UDI
GMDN Term
Cardiopulmonary physiological parameter analysis software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2380 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cardiopulmonary physiological parameter analysis software

ELEFT (Eko Low Ejection Fraction Tool) by Eko Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary physiological parameter analysis software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Eko Devices, Inc.

Sources (1)

  • FDA UDI d18fd172-b9ae-4813-8c93-c54cc68b11d9 35 fields · synced Jun 6, 2026