FDA 510(k)

静脉训练器（型号：FM150，SFM90）

K号: K203746 · 2021-11-10

决定日期2021-11-10

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

Venen-trainer (Model: FM150, SFM90) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Pango Electronic Co., Ltd.. It received FDA 510(k) clearance on 2021-11-10 under 510(k) number K203746. 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 Venen-trainer (Model: FM150, SFM90)?

Venen-trainer (Model: FM150, SFM90) is a medical device that received FDA 510(k) clearance on 2021-11-10. The listed applicant is Shenzhen Pango Electronic Co., Ltd.. The 510(k) number is K203746.

When did Venen-trainer (Model: FM150, SFM90) receive FDA 510(k) clearance?

Venen-trainer (Model: FM150, SFM90) received FDA 510(k) clearance on 2021-11-10, under 510(k) number K203746.

Who is the listed applicant for Venen-trainer (Model: FM150, SFM90)?

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

What is the FDA product code for Venen-trainer (Model: FM150, SFM90)?

The FDA product code for Venen-trainer (Model: FM150, SFM90) is JOW.

列明Shenzhen Pango Electronic 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。

K200716电子血压计 K182597红外温度计 K170151电子血压计 K161845电子血压计

官方来源

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