FDA 510(k)

真迪導航系統

K 號：K192397 · 2020-01-30

決定日期2020-01-30

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

TruDi Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Biosense Webster. It received FDA 510(k) clearance on 2020-01-30 under 510(k) number K192397. 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 TruDi Navigation System?

TruDi Navigation System is a medical device that received FDA 510(k) clearance on 2020-01-30. The listed applicant is Biosense Webster. The 510(k) number is K192397.

When did TruDi Navigation System receive FDA 510(k) clearance?

TruDi Navigation System received FDA 510(k) clearance on 2020-01-30, under 510(k) number K192397.

Who is the listed applicant for TruDi Navigation System?

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

What is the FDA product code for TruDi Navigation System?

The FDA product code for TruDi Navigation System is PGW.

其他以 Biosense Webster 為申請人之記錄

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K161701CARTO ENT 系統

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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官方來源

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