510(k) K201179

GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable by Covidien, LLC — Product Code DQA

K201179 is an FDA 510(k) premarket notification submitted by Covidien, LLC for the device "GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable". The FDA issued a decision of Substantially Equivalent on Jul 20, 2020. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Covidien, LLC has 224 other 510(k) clearances on record.