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FDA 510(k)

十进制推注

K号: K211511 · 2021-07-01

申请人.Decimal, LLC
决定日期2021-07-01
产品代码MUJ
咨询委员会RA
决定实质等同

器械摘要

decimal Bolus is the device name listed in this FDA 510(k) record. The listed applicant is .Decimal, LLC. It received FDA 510(k) clearance on 2021-07-01 under 510(k) number K211511. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the decimal Bolus?

decimal Bolus is a medical device that received FDA 510(k) clearance on 2021-07-01. The listed applicant is .Decimal, LLC. The 510(k) number is K211511.

When did decimal Bolus receive FDA 510(k) clearance?

decimal Bolus received FDA 510(k) clearance on 2021-07-01, under 510(k) number K211511.

Who is the listed applicant for decimal Bolus?

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

What is the FDA product code for decimal Bolus?

The FDA product code for decimal Bolus is MUJ.

相关临床试验

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列明.Decimal, LLC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。

相关器械(代码:MUJ)

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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