FDA 510(k)

研究用不規則心脈監測器手錶（家庭版）、研究用不規則心脈監測器手錶

K 號：K213357 · 2022-07-19

決定日期2022-07-19

產品代碼DXH

諮詢委員會履歷

決定相當於

器材摘要

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.

常見問題

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.

其他以 Verily Life Sciences, LLC 為申請人之記錄

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