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FDA 510(k)

快速重啟

K 號：K203552 · 2020-12-22

申請人Rapid Reboot Recovery Products, LLC
決定日期2020-12-22
產品代碼IRP
諮詢委員會PM
決定相當於

器材摘要

Rapid Reboot is the device name listed in this FDA 510(k) record. The listed applicant is Rapid Reboot Recovery Products, LLC. It received FDA 510(k) clearance on 2020-12-22 under 510(k) number K203552. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Rapid Reboot?

Rapid Reboot is a medical device that received FDA 510(k) clearance on 2020-12-22. The listed applicant is Rapid Reboot Recovery Products, LLC. The 510(k) number is K203552.

When did Rapid Reboot receive FDA 510(k) clearance?

Rapid Reboot received FDA 510(k) clearance on 2020-12-22, under 510(k) number K203552.

Who is the listed applicant for Rapid Reboot?

The FDA 510(k) record lists Rapid Reboot Recovery Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rapid Reboot?

The FDA product code for Rapid Reboot is IRP.

相關臨床試驗

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NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Rapid Reboot Recovery Products, 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。

K182668快速重啟壓縮治療系統

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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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