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FDA 510(k)

CUR型号1

K号: K160052 · 2016-05-20

决定日期2016-05-20
产品代码NUH
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决定实质等同

器械摘要

CUR Model 1 is the device name listed in this FDA 510(k) record. The listed applicant is Thimble Bioelectronics, Inc.. It received FDA 510(k) clearance on 2016-05-20 under 510(k) number K160052. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CUR Model 1?

CUR Model 1 is a medical device that received FDA 510(k) clearance on 2016-05-20. The listed applicant is Thimble Bioelectronics, Inc.. The 510(k) number is K160052.

When did CUR Model 1 receive FDA 510(k) clearance?

CUR Model 1 received FDA 510(k) clearance on 2016-05-20, under 510(k) number K160052.

Who is the listed applicant for CUR Model 1?

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

What is the FDA product code for CUR Model 1?

The FDA product code for CUR Model 1 is NUH.

相关临床试验

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相关器械(代码:NUH)

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。

官方来源

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