FDA 510(k)

SimpleSENSE 平台

K号: K212160 · 2021-09-22

决定日期2021-09-22

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 Platform is the device name listed in this FDA 510(k) record. The listed applicant is Nanowear, Inc.. It received FDA 510(k) clearance on 2021-09-22 under 510(k) number K212160. 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 Platform?

SimpleSENSE Platform is a medical device that received FDA 510(k) clearance on 2021-09-22. The listed applicant is Nanowear, Inc.. The 510(k) number is K212160.

When did SimpleSENSE Platform receive FDA 510(k) clearance?

SimpleSENSE Platform received FDA 510(k) clearance on 2021-09-22, under 510(k) number K212160.

Who is the listed applicant for SimpleSENSE Platform?

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 Platform?

The FDA product code for SimpleSENSE Platform 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 K201669SimpleSENSE K161431SimplECG

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。