FDA 510(k)

一次性SpO2传感器

K号: K200069 · 2020-03-13

申请人Shenzhen Changke Connect Electronics Co., Ltd.

决定日期2020-03-13

产品代码DQA

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

Disposable SpO2 Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Changke Connect Electronics Co., Ltd.. It received FDA 510(k) clearance on 2020-03-13 under 510(k) number K200069. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable SpO2 Sensor?

Disposable SpO2 Sensor is a medical device that received FDA 510(k) clearance on 2020-03-13. The listed applicant is Shenzhen Changke Connect Electronics Co., Ltd.. The 510(k) number is K200069.

When did Disposable SpO2 Sensor receive FDA 510(k) clearance?

Disposable SpO2 Sensor received FDA 510(k) clearance on 2020-03-13, under 510(k) number K200069.

Who is the listed applicant for Disposable SpO2 Sensor?

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

What is the FDA product code for Disposable SpO2 Sensor?

The FDA product code for Disposable SpO2 Sensor is DQA.