FDA 510(k)

HurriChem設備套件

K 號：K222575 · 2022-12-06

決定日期2022-12-06

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

HurriChem Device Kit is the device name listed in this FDA 510(k) record. The listed applicant is Thermasolutions, LLC. It received FDA 510(k) clearance on 2022-12-06 under 510(k) number K222575. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HurriChem Device Kit?

HurriChem Device Kit is a medical device that received FDA 510(k) clearance on 2022-12-06. The listed applicant is Thermasolutions, LLC. The 510(k) number is K222575.

When did HurriChem Device Kit receive FDA 510(k) clearance?

HurriChem Device Kit received FDA 510(k) clearance on 2022-12-06, under 510(k) number K222575.

Who is the listed applicant for HurriChem Device Kit?

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

What is the FDA product code for HurriChem Device Kit?

The FDA product code for HurriChem Device Kit is GCJ.

其他以 Thermasolutions, LLC 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：GCJ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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