510(k) K250233

PreemptiveAI Clinical SDK by Measure Labs, Inc. (Dba Preemptiveai, Inc.) — Product Code DXH

K250233 is an FDA 510(k) premarket notification submitted by Measure Labs, Inc. (Dba Preemptiveai, Inc.) for the device "PreemptiveAI Clinical SDK". The FDA issued a decision of Substantially Equivalent on February 13, 2026. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920.