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)

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 the device name listed in this FDA 510(k) record. The listed applicant is Anumana, Inc.. It received FDA 510(k) clearance on 2023-09-28 under 510(k) 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. The listed applicant is Anumana, Inc.. The 510(k) number is K232699.

When did Low Ejection Fraction AI-ECG Algorithm receive FDA 510(k) clearance?

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

Who is the listed applicant for Low Ejection Fraction AI-ECG Algorithm?

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

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

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.

NCT07270692Detection of Reduced Left Ventricular Ejection Fraction With Three-Lead ECG Using Artificial IntelligenceSUSPENDEDNCT07087613Deep Learning Detection of Pulmonary Hypertension and Low Ejection Fraction Via Digital Stethoscope and 3-Lead ECGRECRUITINGNCT06011252Pacing Characteristics of a Conventional BipolarACTIVE_NOT_RECRUITINGNCT06699056AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable MonitorRECRUITINGNCT07771231Kosmos PLAX EF Pivotal StudyACTIVE_NOT_RECRUITINGNCT07775976Cor360: Clinician-Facing Broad-Spectrum Cardiac Phenotyping and Risk Assessment Using COR® Wearable ECG to Inform Outcomes-Oriented Care PathwaysENROLLING_BY_INVITATION

Other records listing Anumana, 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.

K260300WatchMate SoftwareK253801ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)K252360ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)K250652ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)K233160NeuTrace EP Mapping System v.2.1

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

↑