DVT-4000S
K号: K203417 · 2021-03-28
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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:
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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]
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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。
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。
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息,请务必参考官方记录。
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