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FDA 510(k)

一次性血压计袖带

K号: K222420 · 2022-11-21

决定日期2022-11-21
产品代码DXQ
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

Disposable Blood Pressure Cuff is the device name listed in this FDA 510(k) record. The listed applicant is Wenzhou Xikang Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2022-11-21 under 510(k) number K222420. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable Blood Pressure Cuff?

Disposable Blood Pressure Cuff is a medical device that received FDA 510(k) clearance on 2022-11-21. The listed applicant is Wenzhou Xikang Medical Instruments Co., Ltd.. The 510(k) number is K222420.

When did Disposable Blood Pressure Cuff receive FDA 510(k) clearance?

Disposable Blood Pressure Cuff received FDA 510(k) clearance on 2022-11-21, under 510(k) number K222420.

Who is the listed applicant for Disposable Blood Pressure Cuff?

The FDA 510(k) record lists Wenzhou Xikang Medical Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Blood Pressure Cuff?

The FDA product code for Disposable Blood Pressure Cuff is DXQ.

相关临床试验

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。

列明Wenzhou Xikang Medical Instruments Co., Ltd.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。

相关器械(代码:DXQ)

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。

官方来源

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