510(k) K192608

Disposable SpO2 Sensor by Shenzhen Sino-K Medical Technology Co.,Ltd — Product Code DQA

K192608 is an FDA 510(k) premarket notification submitted by Shenzhen Sino-K Medical Technology Co.,Ltd for the device "Disposable SpO2 Sensor". The FDA issued a decision of Substantially Equivalent on January 24, 2020. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Shenzhen Sino-K Medical Technology Co.,Ltd has at least 2 other 510(k) clearances on record.