510(k) K213357

Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor by Verily Life Sciences, LLC — Product Code DXH

K213357 is an FDA 510(k) premarket notification submitted by Verily Life Sciences, LLC for the device "Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor". The FDA issued a decision of Substantially Equivalent on July 19, 2022. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. Verily Life Sciences, LLC has at least 3 other 510(k) clearances on record.