FDA 510(k)

physIQ 心律和呼吸模块

K号: K193415 · 2020-06-11

决定日期2020-06-11

产品代码DPS

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

physIQ Heart Rhythm and Respiration Module is the device name listed in this FDA 510(k) record. The listed applicant is Physiq, Inc.. It received FDA 510(k) clearance on 2020-06-11 under 510(k) number K193415. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the physIQ Heart Rhythm and Respiration Module?

physIQ Heart Rhythm and Respiration Module is a medical device that received FDA 510(k) clearance on 2020-06-11. The listed applicant is Physiq, Inc.. The 510(k) number is K193415.

When did physIQ Heart Rhythm and Respiration Module receive FDA 510(k) clearance?

physIQ Heart Rhythm and Respiration Module received FDA 510(k) clearance on 2020-06-11, under 510(k) number K193415.

Who is the listed applicant for physIQ Heart Rhythm and Respiration Module?

The FDA 510(k) record lists Physiq, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for physIQ Heart Rhythm and Respiration Module?

The FDA product code for physIQ Heart Rhythm and Respiration Module is DPS.

列明Physiq, Inc.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。

K183322physIQ 心律和呼吸模块 K180234physiQ 心律模块

官方来源

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