510(k) K232495

Sempulse Halo Vital Signs Monitor by Sempulse Corporation — Product Code DQA

K232495 is an FDA 510(k) premarket notification submitted by Sempulse Corporation for the device "Sempulse Halo Vital Signs Monitor". The FDA issued a decision of Substantially Equivalent on May 16, 2024. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700.