FDA 510(k)

研究手表带不规则脉搏监测器（家用），研究手表带不规则脉搏监测器

K号: K213357 · 2022-07-19

决定日期2022-07-19

产品代码DXH

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

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.

常见问题

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.

列明Verily Life Sciences, LLC为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K242508Verily Numetric 视网膜相机 K192415研究手表带不规则脉搏监测器 K182456研究手表

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