FDA 510(k)

Passport 系列患者监护仪（包括 Passport 8，Passport 12）

K号: K153448 · 2016-03-03

申请人Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

决定日期2016-03-03

产品代码MHX

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

Passport Series Patient Monitors (Including Passport 8, Passport 12) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2016-03-03 under 510(k) number K153448. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Passport Series Patient Monitors (Including Passport 8, Passport 12)?

Passport Series Patient Monitors (Including Passport 8, Passport 12) is a medical device that received FDA 510(k) clearance on 2016-03-03. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K153448.

When did Passport Series Patient Monitors (Including Passport 8, Passport 12) receive FDA 510(k) clearance?

Passport Series Patient Monitors (Including Passport 8, Passport 12) received FDA 510(k) clearance on 2016-03-03, under 510(k) number K153448.

Who is the listed applicant for Passport Series Patient Monitors (Including Passport 8, Passport 12)?

The FDA 510(k) record lists Shenzhen Mindray Bio-Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Passport Series Patient Monitors (Including Passport 8, Passport 12)?

The FDA product code for Passport Series Patient Monitors (Including Passport 8, Passport 12) is MHX.

列明Shenzhen Mindray Bio-Medical Electronics Co., Ltd.为申报人的其他记录

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