FDA 510(k)

聽覺神經植入式設備 Osia OSI200，Osia 2 聲音處理器，Osia 調整軟體 2.0，Osia 智能應用程式，聽覺神經植入式設備外科工具

K 號：K191921 · 2019-11-15

決定日期2019-11-15

產品代碼PFO

諮詢委員會中文(台灣): 此醫療設備之規範性文件遵循「醫療規範-v1」政策。以下為該文件之翻譯：此醫療設備已通過美國食品藥品管理局（FDA）的510(k)認證，並獲得PMA許可。該設備的臨床試驗編號為NCTXXXXXXX，並在PubMed上以PMIDXXXXXXX登錄。該設備的識別碼為XXXXXXXX，相關資訊請參考以下網址：[URL]。公司名稱：[公司名稱] 產品名稱：[產品名稱]

決定相當於

器材摘要

Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Cochlear Americas. It received FDA 510(k) clearance on 2019-11-15 under 510(k) number K191921. The device is classified under product code PFO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments?

Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments is a medical device that received FDA 510(k) clearance on 2019-11-15. The listed applicant is Cochlear Americas. The 510(k) number is K191921.

When did Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments receive FDA 510(k) clearance?

Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments received FDA 510(k) clearance on 2019-11-15, under 510(k) number K191921.

Who is the listed applicant for Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments?

The FDA 510(k) record lists Cochlear Americas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments?

The FDA product code for Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments is PFO.

其他以 Cochlear Americas 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。

K260902Cochlear™ Osia® 3(I) 聽覺處理器；Cochlear™ Osia® 3 聽覺處理器；Cochlear™ Osia® 3 充電器；Cochlear™ Osia® 3 Aqua+；Cochlear™ Osia® 調整軟體 3；Cochlear™ Osia® 智能應用程式；Cochlear™ Osia® 系統 K240155耳蜗奧西亞系統 K231604儀器箱 K220922聽覺神經植入系統 Osia 2，Osia OSI200 植入器，Osia 2 聲音處理器，Osia 2 調整軟體，Cochlear MRI 套件 K212136聽覺神經植入式Baha 6系統，聽覺神經植入式Baha調整軟體6，聽覺神經植入式Baha Baha智慧應用程式 K202048聽覺神經植入式Baha 6 Max聽力處理器，Cochlear Baha調整軟體6，Cochlear Baha智能應用程式

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相關器械（代碼：PFO）

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。

官方來源

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