Eko Analysis Software

GUDID 00850010298030

The Eko Analysis Software is intended to provide support to the physician in the evaluation of patients' heart sounds and ECG’s. The software analyzes simultaneous ECG and heart sounds. The software will detect the presence of suspected murmurs in the heart sounds. The software also detects the presence of atrial fibrillation and normal sinus rhythm from the ECG signal. In addition, it calculates certain cardiac time intervals such as heart rate, QRS duration and EMAT. The software does not distinguish between different kinds of murmurs and does not identify other arrhythmias. It is not intended as a sole means of diagnosis. The interpretations of heart sounds and ECG offered by the software are only significant when used in conjunction with physician over-read and is for use on adults (> 18 years)

EKO DEVICES, INC.

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Primary Device ID00850010298030
NIH Device Record Key00d13343-6393-423f-bc36-42cf6b93f25f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEko Analysis Software
Version Model NumberEAS
Company DUNS079670921
Company NameEKO DEVICES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850010298030 [Primary]
GS100850010298030 [Primary]
GS100850010298030 [Primary]
GS100850010298030 [Primary]
GS100850010298030 [Primary]
GS100850010298030 [Primary]
GS100850010298030 [Primary]
GS100850010298030 [Primary]
GS100850010298030 [Primary]
GS100850010298030 [Primary]
GS100850010298030 [Primary]
GS100850010298030 [Primary]
GS100850010298030 [Primary]
GS100850010298030 [Primary]

FDA Product Code

MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-16
Device Publish Date2020-09-08

Devices Manufactured by EKO DEVICES, INC.

00850010298030 - Eko Analysis Software2020-09-16The Eko Analysis Software is intended to provide support to the physician in the evaluation of patients' heart sounds and ECG’s. The software analyzes simultaneous ECG and heart sounds. The software will detect the presence of suspected murmurs in the heart sounds. The software also detects the presence of atrial fibrillation and normal sinus rhythm from the ECG signal. In addition, it calculates certain cardiac time intervals such as heart rate, QRS duration and EMAT. The software does not distinguish between different kinds of murmurs and does not identify other arrhythmias. It is not intended as a sole means of diagnosis. The interpretations of heart sounds and ECG offered by the software are only significant when used in conjunction with physician over-read and is for use on adults (> 18 years)
00850010298030 - Eko Analysis Software2020-09-16 The Eko Analysis Software is intended to provide support to the physician in the evaluation of patients' heart sounds and ECG’
00850010298009 - Eko Core Digital Attachment2020-05-08 The Eko Core Attachment connects to (and digitizes) the analog stethoscope you already own. It attaches to almost all single-tub
00850010298016 - Eko Core Digital Stethoscope2020-05-08 The Eko Core Electronic Stethoscope is a complete electronic stethoscope with digital & analog capabilities that wirelessly pair
00863609000334 - Eko Mobile App iOS2018-11-08 iOS mobile device software for use with Eko products.
00863609000341 - Eko Mobile App Android2018-11-08 Eko mobile app for Android platforms for use with Eko products.
00863609000358 - Eko App Windows2018-11-08 Windows PC Application for use with Eko products.
00863609000327 - DUO2018-08-16
00863609000303 - Eko Core Electronic Stethoscope 2018-03-29 The Eko Core Electronic Stethoscope is a complete electronic stethoscope with digital & analog capabilities that wirelessly pair

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