FDA 510(k)

Medtronic Extended infusion set

K番号: K210544 · 2021-07-16

決定日2021-07-16

製品コードFPA

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Substantially Equivalent

医療機器の概要

Medtronic Extended infusion set is the device name listed in this FDA 510(k) record. The listed applicant is Unomedical A/S. It received FDA 510(k) clearance on 2021-07-16 under 510(k) number K210544. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Medtronic Extended infusion set?

Medtronic Extended infusion set is a medical device that received FDA 510(k) clearance on 2021-07-16. The listed applicant is Unomedical A/S. The 510(k) number is K210544.

When did Medtronic Extended infusion set receive FDA 510(k) clearance?

Medtronic Extended infusion set received FDA 510(k) clearance on 2021-07-16, under 510(k) number K210544.

Who is the listed applicant for Medtronic Extended infusion set?

The FDA 510(k) record lists Unomedical A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medtronic Extended infusion set?

The FDA product code for Medtronic Extended infusion set is FPA.

申請者としてUnomedical A/Sを記載するその他の記録

K192647neria guard Infusion Set K173879MiniMed Mio Advance infusion set K162812Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set K160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®

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