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FDA 510(k)

實用導航外科導引系統 (PNSGS)

K 號:K202184 · 2021-02-24

決定日期2021-02-24
產品代碼OLO
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

Practical Navigation Surgical Guidance System (PNSGS) is the device name listed in this FDA 510(k) record. The listed applicant is Practical Navigation, LLC. It received FDA 510(k) clearance on 2021-02-24 under 510(k) number K202184. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Practical Navigation Surgical Guidance System (PNSGS)?

Practical Navigation Surgical Guidance System (PNSGS) is a medical device that received FDA 510(k) clearance on 2021-02-24. The listed applicant is Practical Navigation, LLC. The 510(k) number is K202184.

When did Practical Navigation Surgical Guidance System (PNSGS) receive FDA 510(k) clearance?

Practical Navigation Surgical Guidance System (PNSGS) received FDA 510(k) clearance on 2021-02-24, under 510(k) number K202184.

Who is the listed applicant for Practical Navigation Surgical Guidance System (PNSGS)?

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

What is the FDA product code for Practical Navigation Surgical Guidance System (PNSGS)?

The FDA product code for Practical Navigation Surgical Guidance System (PNSGS) is OLO.

相關臨床試驗

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相關器械(代碼:OLO)

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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