510(k) K233963

Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) by Taiwan Aulisa Medical Devices Technologies, Inc. — Product Code DQA

K233963 is an FDA 510(k) premarket notification submitted by Taiwan Aulisa Medical Devices Technologies, Inc. for the device "Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)". The FDA issued a decision of Substantially Equivalent on February 25, 2025. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Taiwan Aulisa Medical Devices Technologies, Inc. has at least 8 other 510(k) clearances on record.