EMAS (Eko Murmur Analysis Software)

Basic Information

• Brand Name: EMAS (Eko Murmur Analysis Software)
• Primary DI: 00850010298184
• Version / Model: Version 1.x
• Catalog Number: EMAS
• Company Name: Eko Devices, Inc.
• Labeler DUNS: 079670921
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-17
• Public Version: 2
• Public Version Date: 2025-11-20
• Public Version Status: Update
• Public Device Record Key: c33ac69a-4bbe-4f2e-83aa-4b5466dc67b5

Device Description

The Eko Murmur Analysis Software is intended to provide decision support to clinicians in their evaluation of patients’ heart sounds. The software analyzes heart sounds and phonocardiograms (and ECG signals, when available). The software will automatically detect murmurs that may be present, and the murmur timing and character, including S1, S2, innocent heart murmurs, structural heart murmurs, and the absence of a heart murmur.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQD	Stethoscope, Electronic	Cardiovascular	870.1875	2
DQC	Phonocardiograph	Cardiovascular	870.2390	1
DPS	Electrocardiograph	Cardiovascular	870.2340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47699	Cardiopulmonary physiological parameter analysis software, professional-only	A software program designed to add image processing and/or data analysis capabilities to a computer/workstation for the interpretation and/or screening of cardiopulmonary physiological parameters [e.g., electrocardiogram (ECG), blood pressure, vital capacity (VC)]; data may be uploaded, or collected in real-time by connection (e.g., wired, Bluetooth) to other devices for spot-checks and/or continuous monitoring. It is intended for use exclusively by healthcare professionals and may provide risk assessment for cardiopulmonary events [e.g., acute myocardial infarction (AMI)] or screen for specific conditions (e.g., low ejection fraction). It might include machine learning (ML) technology.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850010298184	GS1