510(k) K250837

Pulse Oximeter by Shanghai Berry Electronic Tech Co., Ltd. — Product Code DQA

K250837 is an FDA 510(k) premarket notification submitted by Shanghai Berry Electronic Tech Co., Ltd. for the device "Pulse Oximeter". The FDA issued a decision of Substantially Equivalent on September 25, 2025. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Shanghai Berry Electronic Tech Co., Ltd. has at least 2 other 510(k) clearances on record.