FDA 510(k)

InPen 剂量計算器

K 號：K190487 · 2020-02-18

決定日期2020-02-18

產品代碼NDC

諮詢委員會AN

決定相當於

器材摘要

InPen Dose Calculator is the device name listed in this FDA 510(k) record. The listed applicant is Companion Medical, Inc.. It received FDA 510(k) clearance on 2020-02-18 under 510(k) number K190487. 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 InPen Dose Calculator?

InPen Dose Calculator is a medical device that received FDA 510(k) clearance on 2020-02-18. The listed applicant is Companion Medical, Inc.. The 510(k) number is K190487.

When did InPen Dose Calculator receive FDA 510(k) clearance?

InPen Dose Calculator received FDA 510(k) clearance on 2020-02-18, under 510(k) number K190487.

Who is the listed applicant for InPen Dose Calculator?

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

What is the FDA product code for InPen Dose Calculator?

The FDA product code for InPen Dose Calculator is NDC.

其他以 Companion Medical, Inc. 為申請人之記錄

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相關器械（代碼：NDC）

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