FDA 510(k)

コンサートメディカルハンズフリー注射器（HFS）

K番号: K153599 · 2016-09-01

決定日2016-09-01

製品コードFRN

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

Concert Medical Hands-Free Syringe (HFS) is the device name listed in this FDA 510(k) record. The listed applicant is Concert Medical, LLC. It received FDA 510(k) clearance on 2016-09-01 under 510(k) number K153599. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Concert Medical Hands-Free Syringe (HFS)?

Concert Medical Hands-Free Syringe (HFS) is a medical device that received FDA 510(k) clearance on 2016-09-01. The listed applicant is Concert Medical, LLC. The 510(k) number is K153599.

When did Concert Medical Hands-Free Syringe (HFS) receive FDA 510(k) clearance?

Concert Medical Hands-Free Syringe (HFS) received FDA 510(k) clearance on 2016-09-01, under 510(k) number K153599.

Who is the listed applicant for Concert Medical Hands-Free Syringe (HFS)?

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

What is the FDA product code for Concert Medical Hands-Free Syringe (HFS)?

The FDA product code for Concert Medical Hands-Free Syringe (HFS) is FRN.

申請者としてConcert Medical, LLCを記載するその他の記録

K153397S-Wire Guidewire System

公式ソース

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