FDA 510(k)

StealthStation FlexENT (9736242)，StealthStation S8 耳鼻喉軟體 (9735762)

K 號：K200723 · 2020-06-26

決定日期2020-06-26

產品代碼PGW

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2020-06-26 under 510(k) number K200723. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)?

StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) is a medical device that received FDA 510(k) clearance on 2020-06-26. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K200723.

When did StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) receive FDA 510(k) clearance?

StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) received FDA 510(k) clearance on 2020-06-26, under 510(k) number K200723.

Who is the listed applicant for StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)?

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

What is the FDA product code for StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)?

The FDA product code for StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) is PGW.

其他以 Medtronic Navigation, Inc. 為申請人之記錄

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相關器械（代碼：PGW）

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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