AccessGUDID - DEVICE: Eko Analysis Software (00850010298030)

GUDID

Device Identifier (DI) Information

Brand Name: Eko Analysis Software
Version or Model: EAS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Eko Devices, Inc.

Primary DI Number: 00850010298030
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079670921 *Terms of Use

Device Description: 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)

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47699	Cardiopulmonary physiological parameter analysis software	A software program designed to add image processing and/or data analysis capabilities to a computer/workstation for the interpretation and/or screening of cardiopulmonary physiological parameters [e.g., electrocardiogram (ECG), blood pressure, vital capacity (VC)]; data may be uploaded, or collected in real-time by connection (e.g., wired, Bluetooth) to other devices for spot-checks and/or continuous monitoring. It is intended for use exclusively by healthcare professionals and may provide risk assessment for cardiopulmonary events [e.g., acute myocardial infarction (AMI)] or screen for specific conditions (e.g., low ejection fraction). It might include machine learning (ML) technology.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
DPS	Electrocardiograph
DQD	Stethoscope, Electronic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 00d13343-6393-423f-bc36-42cf6b93f25f
Public Version Date: December 23, 2024
Public Version Number: 4
DI Record Publish Date: September 08, 2020