FDA 510(k)

Le'Pen

K号: K181597 · 2019-04-01

决定日期2019-04-01

产品代码EBZ

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决定实质等同

器械摘要

Le'Pen is the device name listed in this FDA 510(k) record. The listed applicant is Kmihh, Ltd.. It received FDA 510(k) clearance on 2019-04-01 under 510(k) number K181597. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Le'Pen?

Le'Pen is a medical device that received FDA 510(k) clearance on 2019-04-01. The listed applicant is Kmihh, Ltd.. The 510(k) number is K181597.

When did Le'Pen receive FDA 510(k) clearance?

Le'Pen received FDA 510(k) clearance on 2019-04-01, under 510(k) number K181597.

Who is the listed applicant for Le'Pen?

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

What is the FDA product code for Le'Pen?

The FDA product code for Le'Pen is EBZ.

官方来源

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器械摘要

常见问题

相关器械（代码：EBZ）

官方来源