FDA 510(k)

生物流軟體

K 號：K162571 · 2016-10-13

決定日期2016-10-13

產品代碼DSH

諮詢委員會履歷

決定相當於

器材摘要

Bioflux Software is the device name listed in this FDA 510(k) record. The listed applicant is Biotricity, Inc.. It received FDA 510(k) clearance on 2016-10-13 under 510(k) number K162571. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Bioflux Software?

Bioflux Software is a medical device that received FDA 510(k) clearance on 2016-10-13. The listed applicant is Biotricity, Inc.. The 510(k) number is K162571.

When did Bioflux Software receive FDA 510(k) clearance?

Bioflux Software received FDA 510(k) clearance on 2016-10-13, under 510(k) number K162571.

Who is the listed applicant for Bioflux Software?

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

What is the FDA product code for Bioflux Software?

The FDA product code for Bioflux Software is DSH.

其他以 Biotricity, Inc. 為申請人之記錄

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K172311生物流設備

相關器械（代碼：DSH）

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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