FDA 510(k)

nextaro 転移システム、nextaro va

K番号: K183187 · 2019-03-15

決定日2019-03-15

製品コードLHI

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

nextaro Transfer System, nextaro va is the device name listed in this FDA 510(k) record. The listed applicant is Sfm Medical Devices GmbH. It received FDA 510(k) clearance on 2019-03-15 under 510(k) number K183187. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the nextaro Transfer System, nextaro va?

nextaro Transfer System, nextaro va is a medical device that received FDA 510(k) clearance on 2019-03-15. The listed applicant is Sfm Medical Devices GmbH. The 510(k) number is K183187.

When did nextaro Transfer System, nextaro va receive FDA 510(k) clearance?

nextaro Transfer System, nextaro va received FDA 510(k) clearance on 2019-03-15, under 510(k) number K183187.

Who is the listed applicant for nextaro Transfer System, nextaro va?

The FDA 510(k) record lists Sfm Medical Devices GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for nextaro Transfer System, nextaro va?

The FDA product code for nextaro Transfer System, nextaro va is LHI.

申請者としてSfm Medical Devices GmbHを記載するその他の記録

K241976nextaro® va, 15mm, 5µm K240748nextaro® v, 20/20

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