FDA 510(k)

インスパンペン針、インスパンオリジナルペン針、インスパンエディションペン針

K番号: K203792 · 2023-01-20

決定日2023-01-20

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

Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle is the device name listed in this FDA 510(k) record. The listed applicant is Pikdare Spa. It received FDA 510(k) clearance on 2023-01-20 under 510(k) number K203792. 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 Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle?

Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle is a medical device that received FDA 510(k) clearance on 2023-01-20. The listed applicant is Pikdare Spa. The 510(k) number is K203792.

When did Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle receive FDA 510(k) clearance?

Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle received FDA 510(k) clearance on 2023-01-20, under 510(k) number K203792.

Who is the listed applicant for Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle?

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

What is the FDA product code for Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle?

The FDA product code for Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle is FMI.

申請者としてPikdare Spaを記載するその他の記録

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公式ソース

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