510(k) K213357

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2022
Date Received
October 12, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Device Class
Class II
Regulation Number
870.2920
Review Panel
CV
Submission Type