510(k) K212300

Pulse Oximeter by Shenzhen Mericonn Technology Co., Ltd. — Product Code DQA

K212300 is an FDA 510(k) premarket notification submitted by Shenzhen Mericonn Technology Co., Ltd. for the device "Pulse Oximeter". The FDA issued a decision of Substantially Equivalent on February 25, 2022. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Shenzhen Mericonn Technology Co., Ltd. has at least 1 other 510(k) clearance on record.