FDA 510(k)

PathVisionXL

K 號：K183142 · 2019-03-14

決定日期2019-03-14

產品代碼MWP

諮詢委員會RA

決定相當於

器材摘要

PathVisionXL is the device name listed in this FDA 510(k) record. The listed applicant is Faxitron Bioptics, LLC. It received FDA 510(k) clearance on 2019-03-14 under 510(k) number K183142. The device is classified under product code MWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PathVisionXL?

PathVisionXL is a medical device that received FDA 510(k) clearance on 2019-03-14. The listed applicant is Faxitron Bioptics, LLC. The 510(k) number is K183142.

When did PathVisionXL receive FDA 510(k) clearance?

PathVisionXL received FDA 510(k) clearance on 2019-03-14, under 510(k) number K183142.

Who is the listed applicant for PathVisionXL?

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

What is the FDA product code for PathVisionXL?

The FDA product code for PathVisionXL is MWP.

其他以 Faxitron Bioptics, 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。

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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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