FDA 510(k)

下一代iBOT

K 號：K172601 · 2018-03-02

決定日期2018-03-02

產品代碼IMK

諮詢委員會PM

決定相當於

器材摘要

Next Generation iBOT is the device name listed in this FDA 510(k) record. The listed applicant is Deka Research & Development Corp.. It received FDA 510(k) clearance on 2018-03-02 under 510(k) number K172601. The device is classified under product code IMK. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Next Generation iBOT?

Next Generation iBOT is a medical device that received FDA 510(k) clearance on 2018-03-02. The listed applicant is Deka Research & Development Corp.. The 510(k) number is K172601.

When did Next Generation iBOT receive FDA 510(k) clearance?

Next Generation iBOT received FDA 510(k) clearance on 2018-03-02, under 510(k) number K172601.

Who is the listed applicant for Next Generation iBOT?

The FDA 510(k) record lists Deka Research & Development Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Next Generation iBOT?

The FDA product code for Next Generation iBOT is IMK.

其他以 Deka Research & Development Corp. 為申請人之記錄

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相關器械（代碼：IMK）

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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