FDA 510(k)

TargetCool™ (RM-DT02W)

K 號：K253114 · 2025-10-16

決定日期2025-10-16

產品代碼GEH

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

TargetCool™ (RM-DT02W) is the device name listed in this FDA 510(k) record. The listed applicant is Recensmedical, Inc.. It received FDA 510(k) clearance on 2025-10-16 under 510(k) number K253114. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TargetCool™ (RM-DT02W)?

TargetCool™ (RM-DT02W) is a medical device that received FDA 510(k) clearance on 2025-10-16. The listed applicant is Recensmedical, Inc.. The 510(k) number is K253114.

When did TargetCool™ (RM-DT02W) receive FDA 510(k) clearance?

TargetCool™ (RM-DT02W) received FDA 510(k) clearance on 2025-10-16, under 510(k) number K253114.

Who is the listed applicant for TargetCool™ (RM-DT02W)?

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

What is the FDA product code for TargetCool™ (RM-DT02W)?

The FDA product code for TargetCool™ (RM-DT02W) is GEH.

其他以 Recensmedical, Inc. 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。

K253348TargetCool-e 注意：此翻譯僅根據規定進行，並未考慮具體的醫療設備規範細節。如需更詳細的翻譯，請提供完整的文本。K230599TargetCool™K221234目標冷 K220674目標冷 K203481冷凍維持

相關器械（代碼：GEH）

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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