FDA 510(k)

目標冷

K 號：K221234 · 2022-07-22

決定日期2022-07-22

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 is the device name listed in this FDA 510(k) record. The listed applicant is Recensmedical, Inc.. It received FDA 510(k) clearance on 2022-07-22 under 510(k) number K221234. 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?

TargetCool is a medical device that received FDA 510(k) clearance on 2022-07-22. The listed applicant is Recensmedical, Inc.. The 510(k) number is K221234.

When did TargetCool receive FDA 510(k) clearance?

TargetCool received FDA 510(k) clearance on 2022-07-22, under 510(k) number K221234.

Who is the listed applicant for TargetCool?

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?

The FDA product code for TargetCool 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。

K253114TargetCool™ (RM-DT02W)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™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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