EMAS (Eko Murmur Analysis Software) EMAS

GUDID 00850010298184

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.

Eko Devices, Inc.

Cardiopulmonary physiological parameter analysis software

• Primary Device ID: 00850010298184
• NIH Device Record Key: c33ac69a-4bbe-4f2e-83aa-4b5466dc67b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMAS (Eko Murmur Analysis Software)
• Version Model Number: Version 1.x
• Catalog Number: EMAS
• Company DUNS: 079670921
• Company Name: Eko Devices, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850010298184 [Primary]

FDA Product Code

• DQD: Stethoscope, Electronic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-25
• Device Publish Date: 2025-03-17

Devices Manufactured by Eko Devices, Inc.

• 00850010298733 - CORE 500 Digital Stethoscope - Ruby Earpiece: 2025-03-27 CORE 500 Digital Stethoscope - Ruby Earpiece
• 00850010298245 - CORE 500 Digital Stethoscope FIGS Earpiece - Black: 2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Black
• 00850010298252 - CORE 500 Digital Stethoscope FIGS Earpiece - Grey: 2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Grey
• 00850010298269 - CORE 500 Digital Stethoscope FIGS Earpiece - Mauve: 2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Mauve
• 00850010298276 - CORE 500 Digital Stethoscope FIGS Earpiece - Sandstone: 2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Sandstone
• 00850010298306 - CORE 500 Digital Stethoscope FIGS Earpiece - Royal Blue: 2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Royal Blue
• 00850010298313 - CORE 500 Digital Stethoscope FIGS Earpiece - Moss: 2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Moss
• 00850010298399 - CORE 500 Digital Stethoscope FIGS Earpiece - Pink Ribbon: 2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Pink Ribbon