FDA 510(k)

SimpleSENSE

K号: K201669 · 2020-11-06

决定日期2020-11-06

产品代码DXH

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

SimpleSENSE is the device name listed in this FDA 510(k) record. The listed applicant is Nanowear, Inc.. It received FDA 510(k) clearance on 2020-11-06 under 510(k) number K201669. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the SimpleSENSE?

SimpleSENSE is a medical device that received FDA 510(k) clearance on 2020-11-06. The listed applicant is Nanowear, Inc.. The 510(k) number is K201669.

When did SimpleSENSE receive FDA 510(k) clearance?

SimpleSENSE received FDA 510(k) clearance on 2020-11-06, under 510(k) number K201669.

Who is the listed applicant for SimpleSENSE?

The FDA 510(k) record lists Nanowear, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SimpleSENSE?

The FDA product code for SimpleSENSE is DXH. This falls under the Hematology category.

列明Nanowear, Inc.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。

K232053SimpleSense-BP，SimpleSense-BP 软件应用 K212160SimpleSENSE 平台 K161431SimplECG

官方来源

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