Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor— 510(k) K213357

Name: FDA 510(k) clearance K213357
Creator: U.S. Food and Drug Administration
Published: 2022-07-19

Substantially Equivalent

Verily Life Sciences, LLC

FDA 510(k) clearance K213357 for Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor, Substantially Equivalent on 2022-07-19. Applicant: Verily Life Sciences, LLC. Device class: 2.

Clearance details

Applicant: Verily Life Sciences, LLC
Product code: Code DXH
Device class: Class 2
Regulation: 21 CFR 870.2920
Advisory panel: Cardiovascular
Date received: 2021-10-12
Decision date: 2022-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.