510(k) K252655

Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT) by Shenzhen Imdk Medical Technology Co., Ltd. — Product Code DQA

K252655 is an FDA 510(k) premarket notification submitted by Shenzhen Imdk Medical Technology Co., Ltd. for the device "Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)". The FDA issued a decision of Substantially Equivalent on May 11, 2026. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Shenzhen Imdk Medical Technology Co., Ltd. has at least 6 other 510(k) clearances on record.