510(k) K193343

Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) by Vitalconnect, Inc. — Product Code DRG

K193343 is an FDA 510(k) premarket notification submitted by Vitalconnect, Inc. for the device "Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)". The FDA issued a decision of Substantially Equivalent on April 20, 2020. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. Vitalconnect, Inc. has at least 9 other 510(k) clearances on record.