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FDA 510(k)

BinkieRT

K号: K231852 · 2023-11-15

申请人Papricalab
决定日期2023-11-15
产品代码IYE
咨询委员会RA
决定实质等同

器械摘要

BinkieRT is the device name listed in this FDA 510(k) record. The listed applicant is Papricalab. It received FDA 510(k) clearance on 2023-11-15 under 510(k) number K231852. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BinkieRT?

BinkieRT is a medical device that received FDA 510(k) clearance on 2023-11-15. The listed applicant is Papricalab. The 510(k) number is K231852.

When did BinkieRT receive FDA 510(k) clearance?

BinkieRT received FDA 510(k) clearance on 2023-11-15, under 510(k) number K231852.

Who is the listed applicant for BinkieRT?

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

What is the FDA product code for BinkieRT?

The FDA product code for BinkieRT is IYE.

相关临床试验

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相关器械(代码:IYE)

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官方来源

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