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FDA 510(k)

口袋III

K号: K232302 · 2024-04-26

决定日期2024-04-26
产品代码IYO
咨询委员会RA
决定实质等同

器械摘要

Pocket III is the device name listed in this FDA 510(k) record. The listed applicant is Quantel Medical. It received FDA 510(k) clearance on 2024-04-26 under 510(k) number K232302. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Pocket III?

Pocket III is a medical device that received FDA 510(k) clearance on 2024-04-26. The listed applicant is Quantel Medical. The 510(k) number is K232302.

When did Pocket III receive FDA 510(k) clearance?

Pocket III received FDA 510(k) clearance on 2024-04-26, under 510(k) number K232302.

Who is the listed applicant for Pocket III?

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

What is the FDA product code for Pocket III?

The FDA product code for Pocket III is IYO.

相关临床试验

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列明Quantel Medical为申报人的其他记录

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相关器械(代码:IYO)

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官方来源

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