FDA 510(k)

ゲティング GSS610Nシリーズ蒸気滅菌器

K番号: K201927 · 2021-03-01

決定日2021-03-01

製品コードFLE

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

Getinge GSS610N Series Steam Sterilizer is the device name listed in this FDA 510(k) record. The listed applicant is Maquet GmbH. It received FDA 510(k) clearance on 2021-03-01 under 510(k) number K201927. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Getinge GSS610N Series Steam Sterilizer?

Getinge GSS610N Series Steam Sterilizer is a medical device that received FDA 510(k) clearance on 2021-03-01. The listed applicant is Maquet GmbH. The 510(k) number is K201927.

When did Getinge GSS610N Series Steam Sterilizer receive FDA 510(k) clearance?

Getinge GSS610N Series Steam Sterilizer received FDA 510(k) clearance on 2021-03-01, under 510(k) number K201927.

Who is the listed applicant for Getinge GSS610N Series Steam Sterilizer?

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

What is the FDA product code for Getinge GSS610N Series Steam Sterilizer?

The FDA product code for Getinge GSS610N Series Steam Sterilizer is FLE.

申請者としてMaquet GmbHを記載するその他の記録

K214120GSS610N21シリーズ蒸気滅菌器 K172159ゲティング GSS67Nシリーズ蒸気滅菌器

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