FDA 510(k)

ゲティング GSS67Nシリーズ蒸気滅菌器

K番号: K252307 · 2026-01-22

申請者Maquet GmbH (A Getinge Group Company)

決定日2026-01-22

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Substantially Equivalent

医療機器の概要

Getinge GSS67N Series Steam Sterilizer is the device name listed in this FDA 510(k) record. The listed applicant is Maquet GmbH (A Getinge Group Company). It received FDA 510(k) clearance on 2026-01-22 under 510(k) number K252307. 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 GSS67N Series Steam Sterilizer?

Getinge GSS67N Series Steam Sterilizer is a medical device that received FDA 510(k) clearance on 2026-01-22. The listed applicant is Maquet GmbH (A Getinge Group Company). The 510(k) number is K252307.

When did Getinge GSS67N Series Steam Sterilizer receive FDA 510(k) clearance?

Getinge GSS67N Series Steam Sterilizer received FDA 510(k) clearance on 2026-01-22, under 510(k) number K252307.

Who is the listed applicant for Getinge GSS67N Series Steam Sterilizer?

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

What is the FDA product code for Getinge GSS67N Series Steam Sterilizer?

The FDA product code for Getinge GSS67N Series Steam Sterilizer is FLE.

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ゲティング GSS67Nシリーズ蒸気滅菌器

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：FLE）

公式ソース