FDA 510(k)

IBS 嵌入式系統 II

K 號：K200753 · 2020-06-09

決定日期2020-06-09

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

IBS Implant System II is the device name listed in this FDA 510(k) record. The listed applicant is Innobiosurg Co., Ltd.. It received FDA 510(k) clearance on 2020-06-09 under 510(k) number K200753. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IBS Implant System II?

IBS Implant System II is a medical device that received FDA 510(k) clearance on 2020-06-09. The listed applicant is Innobiosurg Co., Ltd.. The 510(k) number is K200753.

When did IBS Implant System II receive FDA 510(k) clearance?

IBS Implant System II received FDA 510(k) clearance on 2020-06-09, under 510(k) number K200753.

Who is the listed applicant for IBS Implant System II?

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

What is the FDA product code for IBS Implant System II?

The FDA product code for IBS Implant System II is NHA.

其他以 Innobiosurg Co., Ltd. 為申請人之記錄

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K220517IBS 系統 K220079魔核窄系統 K212517魔核系統 K203344預磨鋼钛塊系統 K202418魔法 UCLA 牙槽系統 K202479IBS 偽裝系統

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相關器械（代碼：NHA）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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