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FDA 510(k)

Eko Low Ejection Fraction Tool (ELEFT)

K-Number: K233409 · 2024-03-28

ApplicantEko Health, Inc.
Decision Date2024-03-28
Product CodeQYE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Eko Low Ejection Fraction Tool (ELEFT) is a medical device manufactured by Eko Health, Inc.. It received FDA 510(k) clearance on 2024-03-28 under approval number K233409. The device is classified under product code QYE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Eko Low Ejection Fraction Tool (ELEFT)?

Eko Low Ejection Fraction Tool (ELEFT) is a medical device that received FDA 510(k) clearance on 2024-03-28. It is manufactured by Eko Health, Inc.. The 510(k) number is K233409.

When was Eko Low Ejection Fraction Tool (ELEFT) approved by the FDA?

Eko Low Ejection Fraction Tool (ELEFT) received FDA 510(k) clearance on 2024-03-28, under approval number K233409.

What company makes Eko Low Ejection Fraction Tool (ELEFT)?

Eko Low Ejection Fraction Tool (ELEFT) is manufactured by Eko Health, Inc..

What is the FDA product code for Eko Low Ejection Fraction Tool (ELEFT)?

The FDA product code for Eko Low Ejection Fraction Tool (ELEFT) is QYE.

Related Clinical Trials

NCT07108231 Inspiratory Muscle Training in Hospitalized Heart Failure Patients RECRUITING NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT06671015 A Trial Comparing High-Flow Nasal Cannula Versus Noninvasive Ventilation on Reintubation and Post-Extubation Respiratory Failure in High-Risk Patients With Systolic Heart Failure RECRUITING NCT05677100 Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure RECRUITING NCT05855135 Assessment of Combined CCM and ICD Device in HFrEF ACTIVE_NOT_RECRUITING NCT06304753 ContriBution of Digital RemOte MoniToring to IMPROVing The Effectiveness of Treatment in Patients With Chronic Heart Failure With Low Ejection Fraction COMPLETED

Related PubMed Literature

PMID: 40714034 Relationship between industry payments to physicians and prescription patterns for PCSK9is, ARNis and DOACs: A report from the NCDR PINNACLE registry. American heart journal (2026)

Other Devices by Eko Health, Inc.

K233609CORE 500 Digital Stethoscope K251494Eko Foundation Analysis Software with Transformers (EFAST)

Related Devices (Code: QYE)

K232699Low Ejection Fraction AI-ECG AlgorithmAnumana, Inc. K250649Bunkerhill ECG-EFBunkerHill Health K250652ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)Anumana, Inc. K250119Tempus ECG-Low EFTempus AI, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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