FDA 510(k)

Insulia 球劑伴侶

K 號：K232451 · 2023-12-12

決定日期2023-12-12

產品代碼NDC

諮詢委員會AN

決定相當於

器材摘要

Insulia Bolus 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 2023-12-12 under 510(k) number K232451. 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 Bolus Companion?

Insulia Bolus Companion is a medical device that received FDA 510(k) clearance on 2023-12-12. The listed applicant is Voluntis Sa.. The 510(k) number is K232451.

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

Insulia Bolus Companion received FDA 510(k) clearance on 2023-12-12, under 510(k) number K232451.

Who is the listed applicant for Insulia Bolus 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 Bolus Companion?

The FDA product code for Insulia Bolus Companion is NDC.

其他以 Voluntis Sa. 為申請人之記錄

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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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