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FDA 510(k)

Study Watch with Irregular Pulse Monitor

K-Number: K192415 · 2020-01-17

ApplicantVerily Life Sciences, LLC
Decision Date2020-01-17
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Study Watch with Irregular Pulse Monitor is a medical device manufactured by Verily Life Sciences, LLC. It received FDA 510(k) clearance on 2020-01-17 under approval number K192415. 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?

Study Watch with Irregular Pulse Monitor is a medical device that received FDA 510(k) clearance on 2020-01-17. It is manufactured by Verily Life Sciences, LLC. The 510(k) number is K192415.

When was Study Watch with Irregular Pulse Monitor approved by the FDA?

Study Watch with Irregular Pulse Monitor received FDA 510(k) clearance on 2020-01-17, under approval number K192415.

What company makes Study Watch with Irregular Pulse Monitor?

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?

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

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Related PubMed Literature

PMID: 41029804 Identifying common patterns in journals that retracted papers from paper mills: a cross-sectional study. Research integrity and peer review (2025)

Other Devices by Verily Life Sciences, LLC

K182456Study Watch K213357Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor K242508Verily Numetric Retinal Camera

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Official Source

View on FDA Database →

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

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