510(k) K261367

Corsano CardioWatch 287-2 System by Corsano Health B.V. — Product Code MSX

K261367 is an FDA 510(k) premarket notification submitted by Corsano Health B.V. for the device "Corsano CardioWatch 287-2 System". The FDA issued a decision of Substantially Equivalent on July 26, 2026. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300. Corsano Health B.V. has at least 1 other 510(k) clearance on record.