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.

Cardiac electrophysiology application software

• Primary Device ID: 00850010298030
• NIH Device Record Key: 00d13343-6393-423f-bc36-42cf6b93f25f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eko Analysis Software
• Version Model Number: EAS
• Company DUNS: 079670921
• Company Name: EKO DEVICES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850010298030 [Primary]

FDA Product Code

• MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-16
• Device Publish Date: 2020-09-08

Devices Manufactured by EKO DEVICES, INC.

• 00850010298160 - Eko CORE 500 Digital Stethoscope Chestpiece: 2023-07-18 Eko CORE 500 Digital Stethoscope Chestpiece
• 00850010298177 - Eko CORE 500 Digital Stethoscope Earpiece: 2023-07-18
• 00850010298191 - Eko CORE 500 and CAC500 Standard bundle: 2023-07-18 Eko CORE 500 and CAC500 Standard bundle
• 00850010298207 - Eko CORE 500 and CAC500 Founder's Edition bundle: 2023-07-18
• 00850010298214 - Eko CORE 500 Founder's Edition Chestpiece: 2023-07-18 Eko CORE 500 Founder's Edition Chestpiece
• 00850010298061 - Eko Mobile App Android International: 2021-04-20 Eko mobile app for android international platforms for use with Eko medical devices.
• 00850010298030 - Eko Analysis Software: 2020-09-16The 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 Software: 2020-09-16 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 Attachment: 2020-05-08 The Eko Core Attachment connects to (and digitizes) the analog stethoscope you already own. It attaches to almost all single-tub