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FDA 510(k)

DVT-4000S

K号: K203417 · 2021-03-28

决定日期2021-03-28
产品代码JOW
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

DVT-4000S is the device name listed in this FDA 510(k) record. The listed applicant is Daesung Maref Co., Ltd.. It received FDA 510(k) clearance on 2021-03-28 under 510(k) number K203417. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DVT-4000S?

DVT-4000S is a medical device that received FDA 510(k) clearance on 2021-03-28. The listed applicant is Daesung Maref Co., Ltd.. The 510(k) number is K203417.

When did DVT-4000S receive FDA 510(k) clearance?

DVT-4000S received FDA 510(k) clearance on 2021-03-28, under 510(k) number K203417.

Who is the listed applicant for DVT-4000S?

The FDA 510(k) record lists Daesung Maref Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DVT-4000S?

The FDA product code for DVT-4000S is JOW.

列明Daesung Maref 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。

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相关器械(代码:JOW)

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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