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FDA 510(k)

Canary 道骨延伸器（CTE）搭配 Canary 健康植入報告處理器（CHIRP）系統

K 號：K220413 · 2022-06-22

申請人Canary Medical USA, LLC
決定日期2022-06-22
產品代碼QPP
諮詢委員會或
決定相當於

器材摘要

Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is the device name listed in this FDA 510(k) record. The listed applicant is Canary Medical USA, LLC. It received FDA 510(k) clearance on 2022-06-22 under 510(k) number K220413. The device is classified under product code QPP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System?

Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is a medical device that received FDA 510(k) clearance on 2022-06-22. The listed applicant is Canary Medical USA, LLC. The 510(k) number is K220413.

When did Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System receive FDA 510(k) clearance?

Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System received FDA 510(k) clearance on 2022-06-22, under 510(k) number K220413.

Who is the listed applicant for Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System?

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

What is the FDA product code for Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System?

The FDA product code for Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is QPP.

相關臨床試驗

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。

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 Canary Medical USA, 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。

K234056canturio® se（Canturio智慧擴展）K223803Canary 道骨延伸器（CTE）搭配 Canary 健康植入報告處理器（CHIRP）系統

相關器械（代碼：QPP）

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。

K234056canturio® se（Canturio智慧擴展）Canary Medical USA, LLCK223803Canary 道骨延伸器（CTE）搭配 Canary 健康植入報告處理器（CHIRP）系統Canary Medical USA, LLC

官方來源

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