免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料,僅供一般參考,不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

ThermoChem HT-2000 系統及腹腔高溫治療(IPH)程序套件(HT-2000)

K 號:K240447 · 2025-05-05

決定日期2025-05-05
產品代碼MLW
諮詢委員會GU
決定Unknown

器材摘要

ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) is the device name listed in this FDA 510(k) record. The listed applicant is Thermasolutions, LLC. It received FDA 510(k) clearance on 2025-05-05 under 510(k) number K240447. The device is classified under product code MLW. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常見問題

What is the ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)?

ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) is a medical device that received FDA 510(k) clearance on 2025-05-05. The listed applicant is Thermasolutions, LLC. The 510(k) number is K240447.

When did ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) receive FDA 510(k) clearance?

ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) received FDA 510(k) clearance on 2025-05-05, under 510(k) number K240447.

Who is the listed applicant for ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)?

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 ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)?

The FDA product code for ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) is MLW.

相關臨床試驗

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。

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。

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊,請始終參閱官方記錄。

↑