510(k) K231243

Finger Clip Pulse Oximeter by Guangdong Genial Technology Co., Ltd. — Product Code DQA

K231243 is an FDA 510(k) premarket notification submitted by Guangdong Genial Technology Co., Ltd. for the device "Finger Clip Pulse Oximeter". The FDA issued a decision of Substantially Equivalent on October 31, 2023. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Guangdong Genial Technology Co., Ltd. has at least 4 other 510(k) clearances on record.