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EMAS (Eko Murmur Analysis Software)

FDA UDI

Class II (US FDA UDI)

by Eko Devices, Inc.

Identity

Trade Name
EMAS (Eko Murmur Analysis Software) FDA UDI
Generic Name
Cardiopulmonary physiological parameter analysis software FDA UDI
Device Name
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. FDA UDI
Model / Reference
Version 1.x FDA UDI
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. FDA UDI

Identifiers

Catalog Number
EMAS FDA UDI
Primary DI / UDI-DI
00850010298184 FDA UDI
FDA Product Code
DQD FDA UDI
DQC FDA UDI
DPS FDA UDI
GMDN Term
Cardiopulmonary physiological parameter analysis software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1875 FDA UDI
870.2390 FDA UDI
870.2340 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cardiopulmonary physiological parameter analysis software

EMAS (Eko Murmur Analysis Software) by Eko Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary physiological parameter analysis software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Eko Devices, Inc.

Sources (1)

  • FDA UDI c33ac69a-4bbe-4f2e-83aa-4b5466dc67b5 34 fields · synced May 30, 2026