FDA 510(k)

Renova RP 穿刺泵

K 號：K221042 · 2023-04-19

決定日期2023-04-19

產品代碼BTA

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

Renova RP Centesis Pump is the device name listed in this FDA 510(k) record. The listed applicant is Gi Supply, Inc.. It received FDA 510(k) clearance on 2023-04-19 under 510(k) number K221042. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Renova RP Centesis Pump?

Renova RP Centesis Pump is a medical device that received FDA 510(k) clearance on 2023-04-19. The listed applicant is Gi Supply, Inc.. The 510(k) number is K221042.

When did Renova RP Centesis Pump receive FDA 510(k) clearance?

Renova RP Centesis Pump received FDA 510(k) clearance on 2023-04-19, under 510(k) number K221042.

Who is the listed applicant for Renova RP Centesis Pump?

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

What is the FDA product code for Renova RP Centesis Pump?

The FDA product code for Renova RP Centesis Pump is BTA.

其他以 Gi Supply, Inc. 為申請人之記錄

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相關器械（代碼：BTA）

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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