Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Eko Health, Inc.. It received FDA 510(k) clearance on 2024-03-28 under 510(k) 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. The listed applicant is Eko Health, Inc.. The 510(k) number is K233409.

When did Eko Low Ejection Fraction Tool (ELEFT) receive FDA 510(k) clearance?

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

Who is the listed applicant for Eko Low Ejection Fraction Tool (ELEFT)?

The FDA 510(k) record lists Eko Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07087613Deep Learning Detection of Pulmonary Hypertension and Low Ejection Fraction Via Digital Stethoscope and 3-Lead ECGRECRUITINGNCT027999793D Imaging: Prognostic Role in Pulmonary Arterial HypertensionCOMPLETED

Other records listing Eko Health, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261694CORE 300 Digital StethoscopeK251494Eko Foundation Analysis Software with Transformers (EFAST)K233609CORE 500 Digital Stethoscope

Related Devices (Code: QYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250649Bunkerhill ECG-EFBunkerHill HealthK250652ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)Anumana, Inc.K250119Tempus ECG-Low EFTempus AI, Inc.K232699Low Ejection Fraction AI-ECG AlgorithmAnumana, 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.

↑