FDA 510(k)

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K号: K252861 · 2026-04-07

申请人Hangzhou Tappa Medical Technology Co., Ltd.

决定日期2026-04-07

产品代码DWJ

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

Warming System is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Tappa Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-04-07 under 510(k) number K252861. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Warming System?

Warming System is a medical device that received FDA 510(k) clearance on 2026-04-07. The listed applicant is Hangzhou Tappa Medical Technology Co., Ltd.. The 510(k) number is K252861.

When did Warming System receive FDA 510(k) clearance?

Warming System received FDA 510(k) clearance on 2026-04-07, under 510(k) number K252861.

Who is the listed applicant for Warming System?

FDA 510(k)记录将杭州泰帕医疗科技有限公司列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Warming System?

The FDA product code for Warming System is DWJ.

列明Hangzhou Tappa Medical Technology 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。

K262089一次性保暖毯 K251950Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S)

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