510(k) K190916

VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 by Vitalconnect, Inc. — Product Code DRG

K190916 is an FDA 510(k) premarket notification submitted by Vitalconnect, Inc. for the device "VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20". The FDA issued a decision of Substantially Equivalent on June 7, 2019. 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.