FDA 510(k)

CURA-Temp

K 號：K202965 · 2022-12-21

決定日期2022-12-21

產品代碼EBG

諮詢委員會DE

決定相當於

器材摘要

CURA-Temp is the device name listed in this FDA 510(k) record. The listed applicant is Mgnewton , Ltd.. It received FDA 510(k) clearance on 2022-12-21 under 510(k) number K202965. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CURA-Temp?

CURA-Temp is a medical device that received FDA 510(k) clearance on 2022-12-21. The listed applicant is Mgnewton , Ltd.. The 510(k) number is K202965.

When did CURA-Temp receive FDA 510(k) clearance?

CURA-Temp received FDA 510(k) clearance on 2022-12-21, under 510(k) number K202965.

Who is the listed applicant for CURA-Temp?

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

What is the FDA product code for CURA-Temp?

The FDA product code for CURA-Temp is EBG.

其他以 Mgnewton , Ltd. 為申請人之記錄

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K202963ELEC Master, ELEC Master雙用版

相關器械（代碼：EBG）

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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