510(k) K202743

Med-Link Temp-pulse Oximeter by Shenzhen Med-Link Electronics Tech Co., Ltd. — Product Code DQA

K202743 is an FDA 510(k) premarket notification submitted by Shenzhen Med-Link Electronics Tech Co., Ltd. for the device "Med-Link Temp-pulse Oximeter". The FDA issued a decision of Substantially Equivalent on March 1, 2021. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Shenzhen Med-Link Electronics Tech Co., Ltd. has at least 10 other 510(k) clearances on record.