FDA 510(k)

醫療設備規範文本翻譯： MEDIP PRO

K 號：K191026 · 2019-11-07

決定日期2019-11-07

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

MEDIP PRO is the device name listed in this FDA 510(k) record. The listed applicant is Medical IP Co., Ltd.. It received FDA 510(k) clearance on 2019-11-07 under 510(k) number K191026. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MEDIP PRO?

MEDIP PRO is a medical device that received FDA 510(k) clearance on 2019-11-07. The listed applicant is Medical IP Co., Ltd.. The 510(k) number is K191026.

When did MEDIP PRO receive FDA 510(k) clearance?

MEDIP PRO received FDA 510(k) clearance on 2019-11-07, under 510(k) number K191026.

Who is the listed applicant for MEDIP PRO?

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

What is the FDA product code for MEDIP PRO?

The FDA product code for MEDIP PRO is LLZ.

其他以 Medical IP Co., Ltd. 為申請人之記錄

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K223556深捕

相關器械（代碼：LLZ）

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