Eko Analysis Software
Basic Information
- Brand Name
- Eko Analysis Software
- Primary DI
- 00850010298030
- Version / Model
- EAS
- Company Name
- Eko Devices, Inc.
- Labeler DUNS
- 079670921
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-08
- Public Version
- 3
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- 00d13343-6393-423f-bc36-42cf6b93f25f
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
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Cardiovascular | 870.2300 | 2 |
| DPS | Electrocardiograph | Cardiovascular | 870.2340 | 2 |
| DQD | Stethoscope, Electronic | Cardiovascular | 870.1875 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47699 | Cardiac electrophysiology processing software | A software program designed to add specific image processing and/or data analysis capabilities to a computer for the interpretation and/or screening of cardiac electrophysiology parameters [e.g., electrocardiogram (ECG)]. It is intended for use exclusively by healthcare professionals and may provide risk assessment for cardiac events [e.g., acute myocardial infarction (AMI), acute myocardial ischemic injury (AMII)] or screen for specific conditions (e.g., low ejection fraction). It might include artificial intelligence (AI) and machine learning (ML) technology. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850010298030 | GS1 |