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FDA 510(k)

CONNEQT PULSE

K号: K221742 · 2023-04-21

申请人Atcor Medical
决定日期2023-04-21
产品代码DXN
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

CONNEQT PULSE is the device name listed in this FDA 510(k) record. The listed applicant is Atcor Medical. It received FDA 510(k) clearance on 2023-04-21 under 510(k) number K221742. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CONNEQT PULSE?

CONNEQT PULSE is a medical device that received FDA 510(k) clearance on 2023-04-21. The listed applicant is Atcor Medical. The 510(k) number is K221742.

When did CONNEQT PULSE receive FDA 510(k) clearance?

CONNEQT PULSE received FDA 510(k) clearance on 2023-04-21, under 510(k) number K221742.

Who is the listed applicant for CONNEQT PULSE?

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

What is the FDA product code for CONNEQT PULSE?

The FDA product code for CONNEQT PULSE is DXN.

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。

相关器械(代码:DXN)

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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