FDA.reportPublic FDA data

Eko Analysis Software

Primary DI
00850010298030
Brand
Eko Analysis Software
Company
Eko Devices, Inc.
Model
EAS
Device description
The Eko Analysis Software is intended to provide support to the physician in the evaluation of patients' heart soundsand ECG’s. The software analyzes simultaneous ECG and heart sounds. The software will detect the presence ofsuspected murmurs in the heart sounds. The software also detects the presence of atrial fibrillation and normalsinus rhythm from the ECG signal. In addition, it calculates certain cardiac time intervals such as heart rate, QRSduration and EMAT. The software does not distinguish between different kinds of murmurs and does not identifyother arrhythmias.It is not intended as a sole means of diagnosis. The interpretations of heart sounds and ECG offered by the softwareare only significant when used in conjunction with physician over-read and is for use on adults (> 18 years)
Published
2020-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph
DQDStethoscope, Electronic
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2
DQDStethoscope, ElectronicCardiovascular2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850010298030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850010298030008500102980308500102980300850010298030

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac electrophysiology application softwareA software program designed to add specific image processing and/or data analysis capabilities to a computer for the interpretation of cardiac electrophysiology parameters [e.g., electrocardiogram (ECG)]. It may provide risk assessment for cardiac events [e.g., acute myocardial infarction (AMI), acute myocardial ischemic injury (AMII)] and/or include the ability to record images and movies.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079670921
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810209880019CORE 500 Digital Stethoscope FIGS Earpiece - Rapid Response PinkE8CAC500_FRP2026-04-03
00810209880026CORE 500 Digital Stethoscope FIGS Earpiece - Orange TaffyE8CAC500_FOT2026-04-03
00850010298955CORE 500 Digital Stethoscope - Rose Gold ChestpieceE8COR500_ROG2026-04-03
00850010298962CORE 500 Digital Stethoscope - Rose Gold EarpieceE8CAC500_ROG2026-04-03
00850010298979CORE 500 Digital Stethoscope - Bundle-ROGE8COR503-ROG/ROG2026-04-03
00810209880002CORE 500 Digital Stethoscope FIGS Earpiece - Caribbean BlueE8CAC500_FCB2026-01-29
00810209880040EFAST (Eko Foundation Analysis Software with Transformers)1.x.xEFAST2026-01-29
00850010298146ELEFT (Eko Low Ejection Fraction Tool)v7.xELEFT2025-03-17
00850010298184EMAS (Eko Murmur Analysis Software) Version 1.xEMAS2025-03-17
00850010298894CORE 500 Digital Stethoscope - Cool Blue ChestpieceE8COR500_CBL2025-11-07
00850010298900CORE 500 Digital Stethoscope - Cool Blue EarpieceE8CAC500_CBL2025-11-07
00850010298740CORE 500 Digital Stethoscope - Ruby ChestpieceE8COR500_RED2025-10-15
00850010298917CORE 500 Digital Stethoscope FIGS Earpiece - ElderberryE8CAC500_FEL2025-10-15
00850010298924CORE 500 Digital Stethoscope FIGS Earpiece - Off WhiteE8CAC500_FOW2025-10-15
00850010298726CORE 500 Digital Stethoscope - Electric Pink ChestpieceE8COR500_PNK2025-08-12
00850010298757CORE 500 Digital Stethoscope - Electric Pink EarpieceE8CAC500_PNK2025-08-12
00850010298788CORE 500 Digital Stethoscope - Bundle-SLVE8COR503-SLV/SLV2025-08-12
00850010298795CORE 500 Digital Stethoscope - Bundle-BLKE8COR503-BLK/BLK2025-08-12
00850010298801CORE 500 Digital Stethoscope - Bundle-CHPE8COR503-CHP/CHP2025-08-12
00850010298818CORE 500 Digital Stethoscope FIGS Earpiece - Fight Club PinkE8CAC500_FMG2025-08-12

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