FDA 510(k)

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K号: K212473 · 2022-10-28

决定日期2022-10-28

产品代码MWI

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

Welch Allyn Connex Central Station is the device name listed in this FDA 510(k) record. The listed applicant is Welch Allyn, Inc.. It received FDA 510(k) clearance on 2022-10-28 under 510(k) number K212473. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Welch Allyn Connex Central Station?

Welch Allyn Connex Central Station is a medical device that received FDA 510(k) clearance on 2022-10-28. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K212473.

When did Welch Allyn Connex Central Station receive FDA 510(k) clearance?

Welch Allyn Connex Central Station received FDA 510(k) clearance on 2022-10-28, under 510(k) number K212473.

Who is the listed applicant for Welch Allyn Connex Central Station?

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

What is the FDA product code for Welch Allyn Connex Central Station?

The FDA product code for Welch Allyn Connex Central Station is MWI.

列明Welch Allyn, 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。

K243598Welch Allyn Connex® 360（多款）K241411Welch Allyn Connex® 即时监测仪；901058 生命体征监测仪核心（CSM）K223381iExaminer系统 Panoptic Plus K191013韦尔奇·艾琳诊断心脏病学套件 2.X.X 带肺功能检测选项 K181016Welch Allyn RetinaVue网络 REF 901108 PACS医学影像系统 K171621韦尔奇·艾利恩 Connex 生命体征监测仪，韦尔奇·艾利恩 Connex 集成式壁挂系统，901060 生命体征监测仪

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官方来源

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