510(k) K212065

VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger by Remington Medical, Inc. — Product Code DPW

K212065 is an FDA 510(k) premarket notification submitted by Remington Medical, Inc. for the device "VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger". The FDA issued a decision of Substantially Equivalent on October 7, 2021. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Remington Medical, Inc. has at least 10 other 510(k) clearances on record.