FDA 510(k)

Insignis™ 注射器輸液システム

K番号: K232328 · 2024-03-01

決定日2024-03-01

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]

決定大幅同等

医療機器の概要

Insignis™ Syringe Infusion System is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health Sciences, LLC. It received FDA 510(k) clearance on 2024-03-01 under 510(k) number K232328. 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 Insignis™ Syringe Infusion System?

Insignis™ Syringe Infusion System is a medical device that received FDA 510(k) clearance on 2024-03-01. The listed applicant is Innovative Health Sciences, LLC. The 510(k) number is K232328.

When did Insignis™ Syringe Infusion System receive FDA 510(k) clearance?

Insignis™ Syringe Infusion System received FDA 510(k) clearance on 2024-03-01, under 510(k) number K232328.

Who is the listed applicant for Insignis™ Syringe Infusion System?

The FDA 510(k) record lists Innovative Health Sciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Insignis™ Syringe Infusion System?

The FDA product code for Insignis™ Syringe Infusion System is FPA.

申請者としてInnovative Health Sciences, LLCを記載するその他の記録

K202279Insignis皮下針セット

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