FDA 510(k)

Jade

K号: K201794 · 2020-07-28

申请人OrbusNeich Medical (Shenzhen) Co., Ltd.

决定日期2020-07-28

产品代码LIT

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

Jade is the device name listed in this FDA 510(k) record. The listed applicant is OrbusNeich Medical (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2020-07-28 under 510(k) number K201794. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Jade?

Jade is a medical device that received FDA 510(k) clearance on 2020-07-28. The listed applicant is OrbusNeich Medical (Shenzhen) Co., Ltd.. The 510(k) number is K201794.

When did Jade receive FDA 510(k) clearance?

Jade received FDA 510(k) clearance on 2020-07-28, under 510(k) number K201794.

Who is the listed applicant for Jade?

FDA 510(k)记录将奥布斯尼奇医疗（深圳）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 Jade?

The FDA product code for Jade is LIT.