FDA 510(k)

Pro-Tx 直腸氣球 (PROT-25)

K 號：K223249 · 2023-02-10

決定日期2023-02-10

產品代碼PCT

諮詢委員會RA

決定相當於

器材摘要

Pro-Tx Endorectal Balloon (PROT-25) is the device name listed in this FDA 510(k) record. The listed applicant is Dxtx Medical, Inc.. It received FDA 510(k) clearance on 2023-02-10 under 510(k) number K223249. The device is classified under product code PCT. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pro-Tx Endorectal Balloon (PROT-25)?

Pro-Tx Endorectal Balloon (PROT-25) is a medical device that received FDA 510(k) clearance on 2023-02-10. The listed applicant is Dxtx Medical, Inc.. The 510(k) number is K223249.

When did Pro-Tx Endorectal Balloon (PROT-25) receive FDA 510(k) clearance?

Pro-Tx Endorectal Balloon (PROT-25) received FDA 510(k) clearance on 2023-02-10, under 510(k) number K223249.

Who is the listed applicant for Pro-Tx Endorectal Balloon (PROT-25)?

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

What is the FDA product code for Pro-Tx Endorectal Balloon (PROT-25)?

The FDA product code for Pro-Tx Endorectal Balloon (PROT-25) is PCT.

其他以 Dxtx Medical, Inc. 為申請人之記錄

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相關器械（代碼：PCT）

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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