FDA 510(k)

インスリン注射針内蔵スyringe

K番号: K203211 · 2023-02-09

決定日2023-02-09

製品コードFMF

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

Insulin syringe with integrated needle DL is the device name listed in this FDA 510(k) record. The listed applicant is Dlp Medical Products, Corp.. It received FDA 510(k) clearance on 2023-02-09 under 510(k) number K203211. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Insulin syringe with integrated needle DL?

Insulin syringe with integrated needle DL is a medical device that received FDA 510(k) clearance on 2023-02-09. The listed applicant is Dlp Medical Products, Corp.. The 510(k) number is K203211.

When did Insulin syringe with integrated needle DL receive FDA 510(k) clearance?

Insulin syringe with integrated needle DL received FDA 510(k) clearance on 2023-02-09, under 510(k) number K203211.

Who is the listed applicant for Insulin syringe with integrated needle DL?

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

What is the FDA product code for Insulin syringe with integrated needle DL?

The FDA product code for Insulin syringe with integrated needle DL is FMF.

公式ソース

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インスリン注射針内蔵スyringe

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：FMF）

公式ソース