FDA 510(k)

Dunamis 固定按鈕系統

K 號：K191319 · 2019-08-29

決定日期2019-08-29

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

Dunamis Fixation Button System is the device name listed in this FDA 510(k) record. The listed applicant is Dunamis, LLC. It received FDA 510(k) clearance on 2019-08-29 under 510(k) number K191319. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dunamis Fixation Button System?

Dunamis Fixation Button System is a medical device that received FDA 510(k) clearance on 2019-08-29. The listed applicant is Dunamis, LLC. The 510(k) number is K191319.

When did Dunamis Fixation Button System receive FDA 510(k) clearance?

Dunamis Fixation Button System received FDA 510(k) clearance on 2019-08-29, under 510(k) number K191319.

Who is the listed applicant for Dunamis Fixation Button System?

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

What is the FDA product code for Dunamis Fixation Button System?

The FDA product code for Dunamis Fixation Button System is MBI.

其他以 Dunamis, LLC 為申請人之記錄

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相關器械（代碼：MBI）

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