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FDA 510(k)

RTapp

K号: K191610 · 2019-10-01

申请人Segana, LLC
决定日期2019-10-01
产品代码LLZ
咨询委员会RA
决定实质等同

器械摘要

RTapp is the device name listed in this FDA 510(k) record. The listed applicant is Segana, LLC. It received FDA 510(k) clearance on 2019-10-01 under 510(k) number K191610. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RTapp?

RTapp is a medical device that received FDA 510(k) clearance on 2019-10-01. The listed applicant is Segana, LLC. The 510(k) number is K191610.

When did RTapp receive FDA 510(k) clearance?

RTapp received FDA 510(k) clearance on 2019-10-01, under 510(k) number K191610.

Who is the listed applicant for RTapp?

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

What is the FDA product code for RTapp?

The FDA product code for RTapp is LLZ.

相关临床试验

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相关器械(代码:LLZ)

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官方来源

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