510(k) K242455

AViTA Pulse Oximeter (SP62B) by Avita Corporation — Product Code DQA

K242455 is an FDA 510(k) premarket notification submitted by Avita Corporation for the device "AViTA Pulse Oximeter (SP62B)". The FDA issued a decision of Substantially Equivalent on February 19, 2025. 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.