Therm-X
K 號：K231912 · 2023-07-27
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器材摘要
Therm-X 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 2023-07-27 under 510(k) number K231912. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Therm-X?
Therm-X is a medical device that received FDA 510(k) clearance on 2023-07-27. The listed applicant is Zenith Technical Innovations. The 510(k) number is K231912.
When did Therm-X receive FDA 510(k) clearance?
Therm-X received FDA 510(k) clearance on 2023-07-27, under 510(k) number K231912.
Who is the listed applicant for Therm-X?
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?
The FDA product code for Therm-X is IRP.
相關臨床試驗
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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。
相關器械（代碼：IRP）
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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