510(k) K240229

Masimo W1 by Masimo Corporation — Product Code DPS

K240229 is an FDA 510(k) premarket notification submitted by Masimo Corporation for the device "Masimo W1". The FDA issued a decision of Substantially Equivalent on August 8, 2024. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Masimo Corporation has at least 10 other 510(k) clearances on record.