Corsano CardioWatch 287-2 System— 510(k) K261367

Name: FDA 510(k) clearance K261367
Creator: U.S. Food and Drug Administration
Published: 2026-07-26

Substantially Equivalent

Corsano Health B.V.

FDA 510(k) clearance K261367 for Corsano CardioWatch 287-2 System, Substantially Equivalent on 2026-07-26. Applicant: Corsano Health B.V.. Device class: 2.

Clearance details

Applicant: Corsano Health B.V.
Product code: Code MSX
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2026-04-27
Decision date: 2026-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: The Hague, NL

Download summary PDF View on FDA.gov ↗

Recent devices under product code MSX

view all

K253654 — IntelliVue Measurement Rack 6000 (867317)2026-03-30
K243270 — TigerConnect Alarm Management2025-09-30
K242728 — BeneVision Central Monitoring System2025-07-31
K242750 — Central Station2025-06-05
K242842 — ANNE View, Central Hub2025-01-08

More clearances from Corsano Health B.V.

view all

K232548 — Corsano CardioWatch 287-2 System2024-03-22

Adverse events under product code MSX

product code MSX

Death: 59
Total: 59

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.