CardioWatch 287-2 System
by Corsano Health B.V. 2 variants
510(k) K232548
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK232548 | Date22 Mar 2024 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Full name
- Corsano CardioWatch 287-2 System
- 510(k) Number
- FDA Product Code
- MSX
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2300
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The CardioWatch 287-2 System is a Network and Communication System, Physiological Monitor designed for remote patient monitoring. It measures electrodermal activity (EDA/GSR) to assess skin conductivity, providing insights into emotional arousal and stress levels in adult patients aged 22 and older. The device integrates wearable technology with digital platforms for continuous health tracking.
The system comprises a wrist-worn monitoring bracelet, a web-based browser platform, and a mobile application for data visualization. Supplied as a reusable device with non-sterile components, it operates in non-MRI environments. Authorized under FDA 510K and MDR, the system adheres to Class II regulatory standards (Regulation Number: 870.2300) and is intended for clinical or home-use settings. No specific sterility or single-use designation is noted in the regulatory data.
Other devices from Corsano Health B.V.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the Corsano CardioWatch 287-2 System and who is it designed for?
The Corsano CardioWatch 287-2 System is designed for remote patient monitoring by measuring electrodermal activity (EDA/GSR) to assess skin conductivity. This provides insights into emotional arousal and stress levels in adult patients aged 22 and older. It integrates wearable technology with digital platforms for continuous health tracking, suitable for both clinical and home-use environments.
How is the Corsano CardioWatch 287-2 System supplied, and is it reusable or single-use?
The system is supplied as a reusable device with non-sterile components, consisting of a wrist-worn monitoring bracelet, a web-based browser platform, and a mobile application. Since it is explicitly labeled as reusable, it is not intended for single-use.
Can the Corsano CardioWatch 287-2 System be used in an MRI environment?
No, the device is explicitly noted as operating in non-MRI environments, so it should not be used in areas where MRI scans are conducted.
What regulatory pathways has the Corsano CardioWatch 287-2 System undergone, and what class does it fall under?
The system has been authorized under both the FDA 510K pathway and the EU Medical Device Regulation (MDR). It adheres to Class II regulatory standards, as indicated by the regulation number 870.2300, and is intended for use in remote patient monitoring.
What types of data visualization and platform integration does the Corsano CardioWatch 287-2 System offer?
The system integrates a wrist-worn monitoring bracelet with a web-based browser platform and a mobile application, allowing for continuous health tracking and data visualization. This setup enables real-time monitoring of skin conductivity (EDA/GSR) to assess stress and emotional arousal.