510(k) K192385

ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable by Ivwatch, LLC — Product Code PMS

K192385 is an FDA 510(k) premarket notification submitted by Ivwatch, LLC for the device "ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable". The FDA issued a decision of Substantially Equivalent on Jul 2, 2020. The device falls under product code PMS (Peripheral Intravenous (Piv) Infiltration Monitor), a Class II device regulated under 21 CFR 880.5725. Ivwatch, LLC has at least 5 other 510(k) clearances on record.