Singapore HSA registration DE0510140
Eko Health Eko Analysis Software (EAS)
Singapore·CLASS B·Eko Health, Inc.·Registered December 12, 2024Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0510140
- Registration Date
- December 12, 2024
- Retention Due Date
- December 11, 2025
Product 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 and 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).
Product Owner
- Name
- Eko Health, Inc.
- Short Name
- Eko Health, Inc.
- Address
- 2100 Powell Street, Suite 300, Emeryville, CA 94608, UNITED STATES
Registrant
- Address
- 116 CHANGI ROAD, WIS@CHANGI, #04-05, SINGAPORE 419718
Model information
- Model Name(s)
- Eko Analysis Software (EAS)
- Model Identifier(s)
- EAS
About this record
Access comprehensive regulatory information for Eko Health Eko Analysis Software (EAS) in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510140 and owned by Eko Health, Inc.. The device was registered on December 12, 2024.
This page provides complete registration details including product owner information, registrant details, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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