FDA 510(k)

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

Número K: K213357 · 2022-07-19

Data da decisão2022-07-19

Código do produtoDXH

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Verily Life Sciences, LLC. It received FDA 510(k) clearance on 2022-07-19 under 510(k) 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.

Perguntas frequentes

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. The listed applicant is Verily Life Sciences, LLC. The 510(k) number is K213357.

When did Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor receive FDA 510(k) clearance?

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

Who is the listed applicant for Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor?

The FDA 510(k) record lists Verily Life Sciences, LLC as the applicant. This does not by itself establish the device manufacturer.

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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