FDA 510(k)

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

K-Number: K213357 · 2022-07-19

Decision Date2022-07-19

Product CodeDXH

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor is a medical device manufactured by Verily Life Sciences, LLC. It received FDA 510(k) clearance on 2022-07-19 under approval number K213357. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor?

Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor is a medical device that received FDA 510(k) clearance on 2022-07-19. It is manufactured by Verily Life Sciences, LLC. The 510(k) number is K213357.

When was Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor approved by the FDA?

Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor received FDA 510(k) clearance on 2022-07-19, under approval number K213357.

What company makes Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor?

Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor is manufactured by Verily Life Sciences, LLC.

What is the FDA product code for Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor?

The FDA product code for Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor is DXH. This falls under the Hematology category.

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Related PubMed Literature

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Other Devices by Verily Life Sciences, LLC

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.