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FDA 510(k)

Corsano CardioWatch 287-2 System

K-Number: K261367 · 2026-07-26

ApplicantCorsano Health B.V.
Decision Date2026-07-26
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Corsano CardioWatch 287-2 System is the device name listed in this FDA 510(k) record. The listed applicant is Corsano Health B.V.. It received FDA 510(k) clearance on 2026-07-26 under 510(k) number K261367. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Corsano CardioWatch 287-2 System?

Corsano CardioWatch 287-2 System is a medical device that received FDA 510(k) clearance on 2026-07-26. The listed applicant is Corsano Health B.V.. The 510(k) number is K261367.

When did Corsano CardioWatch 287-2 System receive FDA 510(k) clearance?

Corsano CardioWatch 287-2 System received FDA 510(k) clearance on 2026-07-26, under 510(k) number K261367.

Who is the listed applicant for Corsano CardioWatch 287-2 System?

The FDA 510(k) record lists Corsano Health B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Corsano CardioWatch 287-2 System?

The FDA product code for Corsano CardioWatch 287-2 System is MSX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06508619Blood Pressure Treatment by the Corsano CardioWatch 287-2 Evaluation StudyCOMPLETEDNCT06942338Comparative Evaluation of Body Temperature Measurement Using the CardioWatch 287-2 in an Intensive Care Setting.NOT_YET_RECRUITINGNCT07633886Multi-Centre Based Evaluation of the Performance and Safety of the Corsano CardioWatch 287-2 Blood Pressure Monitoring Device at Wrist Against BP-Cuff Measurements (COR-BP)NOT_YET_RECRUITINGNCT07684807Synchronised ECG and PPG Data Collection for AI-based QT/QTc Reconstruction (ILECS-ECGPPG)NOT_YET_RECRUITING

Other records listing Corsano Health B.V. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232548Corsano CardioWatch 287-2 System

Related Devices (Code: MSX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbHK243270TigerConnect Alarm ManagementTigerconnectK242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.K242750Central StationNihon Kohden Digital Health Solutions, LLCK242842ANNE View, Central HubSibel Health, Inc.K241397HinscopeHinlab Sas

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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