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

FDA 510(k)

Low Ejection Fraction AI-ECG Algorithm

K-Number: K232699 · 2023-09-28

ApplicantAnumana, Inc.
Decision Date2023-09-28
Product CodeQYE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Low Ejection Fraction AI-ECG Algorithm is a medical device manufactured by Anumana, Inc.. It received FDA 510(k) clearance on 2023-09-28 under approval number K232699. 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 Low Ejection Fraction AI-ECG Algorithm?

Low Ejection Fraction AI-ECG Algorithm is a medical device that received FDA 510(k) clearance on 2023-09-28. It is manufactured by Anumana, Inc.. The 510(k) number is K232699.

When was Low Ejection Fraction AI-ECG Algorithm approved by the FDA?

Low Ejection Fraction AI-ECG Algorithm received FDA 510(k) clearance on 2023-09-28, under approval number K232699.

What company makes Low Ejection Fraction AI-ECG Algorithm?

Low Ejection Fraction AI-ECG Algorithm is manufactured by Anumana, Inc..

What is the FDA product code for Low Ejection Fraction AI-ECG Algorithm?

The FDA product code for Low Ejection Fraction AI-ECG Algorithm 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 Anumana, Inc.

K233160NeuTrace EP Mapping System v.2.1 K250652ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) K253801ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) K252360ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)

Related Devices (Code: QYE)

K233409Eko Low Ejection Fraction Tool (ELEFT)Eko Health, 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.

↑