Cleared Traditional

Study Watch with Irregular Pulse Monitor

K192415 · Verily Life Sciences, LLC · Cardiovascular
Jan 2020
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K192415 is an FDA 510(k) clearance for the 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 January 17, 2020, 135 days after receiving the submission on September 4, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2920.

Submission Details

510(k) Number K192415 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 2019
Decision Date January 17, 2020
Days to Decision 135 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXH — Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2920

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