FDA 510(k)

Insulia 糖尿病管理夥伴

K 號：K161433 · 2016-11-09

決定日期2016-11-09

產品代碼NDC

諮詢委員會AN

決定相當於

器材摘要

Insulia Diabetes Management Companion is the device name listed in this FDA 510(k) record. The listed applicant is Voluntis Sa.. It received FDA 510(k) clearance on 2016-11-09 under 510(k) number K161433. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Insulia Diabetes Management Companion?

Insulia Diabetes Management Companion is a medical device that received FDA 510(k) clearance on 2016-11-09. The listed applicant is Voluntis Sa.. The 510(k) number is K161433.

When did Insulia Diabetes Management Companion receive FDA 510(k) clearance?

Insulia Diabetes Management Companion received FDA 510(k) clearance on 2016-11-09, under 510(k) number K161433.

Who is the listed applicant for Insulia Diabetes Management Companion?

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

What is the FDA product code for Insulia Diabetes Management Companion?

The FDA product code for Insulia Diabetes Management Companion is NDC.

其他以 Voluntis Sa. 為申請人之記錄

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。

K232451Insulia 球劑伴侶 K202596Insulia 糖尿病管理夥伴 K172177Insulia 糖尿病管理夥伴 K170669Insulia 糖尿病管理夥伴

相關器械（代碼：NDC）

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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