FDA 510(k)

我行

K 號：K192294 · 2020-07-31

決定日期2020-07-31

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

I Do is the device name listed in this FDA 510(k) record. The listed applicant is I DO Biotech Co., Ltd.. It received FDA 510(k) clearance on 2020-07-31 under 510(k) number K192294. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the I Do?

I Do is a medical device that received FDA 510(k) clearance on 2020-07-31. The listed applicant is I DO Biotech Co., Ltd.. The 510(k) number is K192294.

When did I Do receive FDA 510(k) clearance?

I Do received FDA 510(k) clearance on 2020-07-31, under 510(k) number K192294.

Who is the listed applicant for I Do?

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

What is the FDA product code for I Do?

The FDA product code for I Do is DZE.

相關器械（代碼：DZE）

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官方來源

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