FDA 510(k)

iCodeConnect

K 號：K160127 · 2016-11-10

決定日期2016-11-10

產品代碼BZD

諮詢委員會AN

決定相當於

器材摘要

iCodeConnect is the device name listed in this FDA 510(k) record. The listed applicant is 3B Medical, Inc.. It received FDA 510(k) clearance on 2016-11-10 under 510(k) number K160127. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the iCodeConnect?

iCodeConnect is a medical device that received FDA 510(k) clearance on 2016-11-10. The listed applicant is 3B Medical, Inc.. The 510(k) number is K160127.

When did iCodeConnect receive FDA 510(k) clearance?

iCodeConnect received FDA 510(k) clearance on 2016-11-10, under 510(k) number K160127.

Who is the listed applicant for iCodeConnect?

The FDA 510(k) record lists 3B Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iCodeConnect?

The FDA product code for iCodeConnect is BZD.

其他以 3B Medical, Inc. 為申請人之記錄

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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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