FDA 510(k)

Therm-X (家庭用); Therm-X (AT)

K 號：K240125 · 2024-06-21

決定日期2024-06-21

產品代碼JOW

諮詢委員會履歷

決定相當於

器材摘要

Therm-X (Home); Therm-X (AT) is the device name listed in this FDA 510(k) record. The listed applicant is Zenith Technical Innovations. It received FDA 510(k) clearance on 2024-06-21 under 510(k) number K240125. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Therm-X (Home); Therm-X (AT)?

Therm-X (Home); Therm-X (AT) is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is Zenith Technical Innovations. The 510(k) number is K240125.

When did Therm-X (Home); Therm-X (AT) receive FDA 510(k) clearance?

Therm-X (Home); Therm-X (AT) received FDA 510(k) clearance on 2024-06-21, under 510(k) number K240125.

Who is the listed applicant for Therm-X (Home); Therm-X (AT)?

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

What is the FDA product code for Therm-X (Home); Therm-X (AT)?

The FDA product code for Therm-X (Home); Therm-X (AT) is JOW.

其他以 Zenith Technical Innovations 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。

K231912Therm-X K193550Therm-X K190854Therm-X K181149Therm-X Pro, Therm-X AT, Therm-X Pro 運動員

相關器械（代碼：JOW）

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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