510(k) K211588

Caretaker Platform, VitalStream Platform, CT5 by Caretaker Medical — Product Code DXN

K211588 is an FDA 510(k) premarket notification submitted by Caretaker Medical for the device "Caretaker Platform, VitalStream Platform, CT5". The FDA issued a decision of Substantially Equivalent on August 13, 2021. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Caretaker Medical has at least 5 other 510(k) clearances on record.