Corsano CardioWatch 287-2 System— 510(k) K261367
Substantially EquivalentCorsano 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.
Summary
Corsano Health's CardioWatch 287-2 System is filed under MSX, physiological monitor network and communication systems. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 870.2300. The Neurology review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.
Corsano Health filed from The Hague, Netherlands. The decision came 90 calendar days after FDA received it (April 27 to July 26, 2026).
Clearance details
- Applicant
- Corsano Health B.V.
- Product code
- Product code MSX
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- The Hague, NL
Recent devices under product code MSX
view allMore clearances from Corsano Health B.V.
view allAdverse events under product code MSX
product code MSX- Death
- 59
- Total
- 59
Source: openFDA MAUDE database, through . 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.