Eko Analysis Software - The Eko Analysis Software is intended to provide - Eko Devices, Inc.

Duns Number:079670921

Device Description: The Eko Analysis Software is intended to provide support to the physician in the evaluatio 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)

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More Product Details

Catalog Number

-

Brand Name

Eko Analysis Software

Version/Model Number

EAS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

DPS

Product Code Name

Electrocardiograph

Device Record Status

Public Device Record Key

00d13343-6393-423f-bc36-42cf6b93f25f

Public Version Date

April 12, 2021

Public Version Number

2

DI Record Publish Date

September 08, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EKO DEVICES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 6