FDA 510(k)

DropSafe 安全針

K番号: K211716 · 2022-01-07

決定日2022-01-07

製品コードFMI

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

DropSafe Safety Pen Needles is the device name listed in this FDA 510(k) record. The listed applicant is Htl Strefa SA. It received FDA 510(k) clearance on 2022-01-07 under 510(k) number K211716. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the DropSafe Safety Pen Needles?

DropSafe Safety Pen Needles is a medical device that received FDA 510(k) clearance on 2022-01-07. The listed applicant is Htl Strefa SA. The 510(k) number is K211716.

When did DropSafe Safety Pen Needles receive FDA 510(k) clearance?

DropSafe Safety Pen Needles received FDA 510(k) clearance on 2022-01-07, under 510(k) number K211716.

Who is the listed applicant for DropSafe Safety Pen Needles?

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

What is the FDA product code for DropSafe Safety Pen Needles?

The FDA product code for DropSafe Safety Pen Needles is FMI.

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DropSafe 安全針

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：FMI）

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