510(k) K190560

SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface by Nonin Medical, Inc. — Product Code MUD

K190560 is an FDA 510(k) premarket notification submitted by Nonin Medical, Inc. for the device "SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface". The FDA issued a decision of Substantially Equivalent on May 2, 2019. The device falls under product code MUD (Oximeter, Tissue Saturation), a Class II device regulated under 21 CFR 870.2700. Nonin Medical, Inc. has at least 10 other 510(k) clearances on record.