Cleared Traditional

Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor

K213357 · Verily Life Sciences, LLC · Cardiovascular

Jul 2022

Decision

280d

Days

Class 2

Risk

About This 510(k) Submission

K213357 is an FDA 510(k) clearance for the Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor, a Transmitters And Receivers, Electrocardiograph, Telephone (Class II — Special Controls, product code DXH), submitted by Verily Life Sciences, LLC (South San Francisco, US). The FDA issued a Cleared decision on July 19, 2022, 280 days after receiving the submission on October 12, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2920.

Submission Details

510(k) Number	K213357 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 12, 2021
Decision Date	July 19, 2022
Days to Decision	280 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF