FDA 510(k)

canturio® se（Canturio智慧擴展）

K 號：K234056 · 2024-04-24

決定日期2024-04-24

產品代碼QPP

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決定相當於

器材摘要

canturio® se (Canturio Smart Extension) 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 2024-04-24 under 510(k) number K234056. 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 canturio® se (Canturio Smart Extension)?

canturio® se (Canturio Smart Extension) is a medical device that received FDA 510(k) clearance on 2024-04-24. The listed applicant is Canary Medical USA, LLC. The 510(k) number is K234056.

When did canturio® se (Canturio Smart Extension) receive FDA 510(k) clearance?

canturio® se (Canturio Smart Extension) received FDA 510(k) clearance on 2024-04-24, under 510(k) number K234056.

Who is the listed applicant for canturio® se (Canturio Smart Extension)?

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 canturio® se (Canturio Smart Extension)?

The FDA product code for canturio® se (Canturio Smart Extension) is QPP.

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。

K223803Canary 道骨延伸器（CTE）搭配 Canary 健康植入報告處理器（CHIRP）系統 K220413Canary 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。

K223803Canary 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 K220413Canary 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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