FDA 510(k)

生物貼標系統

K 號：K191614 · 2019-12-18

決定日期2019-12-18

產品代碼DRG

諮詢委員會履歷

決定相當於

器材摘要

BioSticker System is the device name listed in this FDA 510(k) record. The listed applicant is Biointellisense, Inc.. It received FDA 510(k) clearance on 2019-12-18 under 510(k) number K191614. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BioSticker System?

BioSticker System is a medical device that received FDA 510(k) clearance on 2019-12-18. The listed applicant is Biointellisense, Inc.. The 510(k) number is K191614.

When did BioSticker System receive FDA 510(k) clearance?

BioSticker System received FDA 510(k) clearance on 2019-12-18, under 510(k) number K191614.

Who is the listed applicant for BioSticker System?

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

What is the FDA product code for BioSticker System?

The FDA product code for BioSticker System is DRG.

其他以 Biointellisense, Inc. 為申請人之記錄

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K241101生物按鈕系統

相關器械（代碼：DRG）

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