510(k) K230813

BlueStar and BlueStar Rx by Welldoc, Inc. — Product Code NDC

K230813 is an FDA 510(k) premarket notification submitted by Welldoc, Inc. for the device "BlueStar and BlueStar Rx". The FDA issued a decision of Substantially Equivalent on July 28, 2023. The device falls under product code NDC (Calculator, Drug Dose), a Class II device regulated under 21 CFR 868.1890. Welldoc, Inc. has at least 10 other 510(k) clearances on record.