FDA 510(k)

Panda iRes 加熱器，Giraffe 加熱器

K 號：K201628 · 2021-02-12

決定日期2021-02-12

產品代碼FMT

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Panda iRes Warmer, Giraffe Warmer is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2021-02-12 under 510(k) number K201628. The device is classified under product code FMT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Panda iRes Warmer, Giraffe Warmer?

Panda iRes Warmer, Giraffe Warmer is a medical device that received FDA 510(k) clearance on 2021-02-12. The listed applicant is GE Healthcare. The 510(k) number is K201628.

When did Panda iRes Warmer, Giraffe Warmer receive FDA 510(k) clearance?

Panda iRes Warmer, Giraffe Warmer received FDA 510(k) clearance on 2021-02-12, under 510(k) number K201628.

Who is the listed applicant for Panda iRes Warmer, Giraffe Warmer?

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

What is the FDA product code for Panda iRes Warmer, Giraffe Warmer?

The FDA product code for Panda iRes Warmer, Giraffe Warmer is FMT.

其他以 GE Healthcare 為申請人之記錄

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