510(k) K180685

AS-3XX Series Fingertip Pulse Oximeter by Xiamen Acurio Instruments Co., Ltd. — Product Code DQA

K180685 is an FDA 510(k) premarket notification submitted by Xiamen Acurio Instruments Co., Ltd. for the device "AS-3XX Series Fingertip Pulse Oximeter". The FDA issued a decision of Substantially Equivalent on Nov 29, 2018. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Xiamen Acurio Instruments Co., Ltd. has 1 other 510(k) clearance on record.