510(k) K252448

AViTA Pulse Oximeter (SP61) by Avita Corporation — Product Code DQA

K252448 is an FDA 510(k) premarket notification submitted by Avita Corporation for the device "AViTA Pulse Oximeter (SP61)". The FDA issued a decision of Substantially Equivalent on February 27, 2026. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Avita Corporation has at least 10 other 510(k) clearances on record.