510(k) K190073

Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub by Current Health , Ltd. — Product Code MSX

K190073 is an FDA 510(k) premarket notification submitted by Current Health , Ltd. for the device "Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub". The FDA issued a decision of Substantially Equivalent on March 27, 2019. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300. Current Health , Ltd. has at least 4 other 510(k) clearances on record.