510(k) K233956

Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) by Taiwan Aulisa Medical Devices Technologies, Inc. — Product Code DQA

K233956 is an FDA 510(k) premarket notification submitted by Taiwan Aulisa Medical Devices Technologies, Inc. for the device "Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)". The FDA issued a decision of Substantially Equivalent on January 30, 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.