510(k) K240092

Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504) by Shenzhen Yimi Life Technology Co., Ltd. — Product Code DQA

K240092 is an FDA 510(k) premarket notification submitted by Shenzhen Yimi Life Technology Co., Ltd. for the device "Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504)". The FDA issued a decision of Substantially Equivalent on Oct 25, 2024. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700.