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FDA 510(k)

DiamondTOUCH Inflation Device and Fluid Dispensing Syringe

K号: K160107 · 2016-07-29

申请人Merit Medical Systems, Inc.
决定日期2016-07-29
产品代码DXT
咨询委员会CV
决定Unknown

器械摘要

DiamondTOUCH Inflation Device and Fluid Dispensing Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2016-07-29 under 510(k) number K160107. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

常见问题

What is the DiamondTOUCH Inflation Device and Fluid Dispensing Syringe?

DiamondTOUCH Inflation Device and Fluid Dispensing Syringe is a medical device that received FDA 510(k) clearance on 2016-07-29. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K160107.

When did DiamondTOUCH Inflation Device and Fluid Dispensing Syringe receive FDA 510(k) clearance?

DiamondTOUCH Inflation Device and Fluid Dispensing Syringe received FDA 510(k) clearance on 2016-07-29, under 510(k) number K160107.

Who is the listed applicant for DiamondTOUCH Inflation Device and Fluid Dispensing Syringe?

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

What is the FDA product code for DiamondTOUCH Inflation Device and Fluid Dispensing Syringe?

The FDA product code for DiamondTOUCH Inflation Device and Fluid Dispensing Syringe is DXT.

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列明Merit Medical Systems, Inc.为申报人的其他记录

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相关器械（代码：DXT）

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。

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官方来源

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