FDA 510(k)

Welch Allyn RetinaVue 網路參考編號 901108 PACS 医學影像系統

K 號：K181016 · 2018-07-16

決定日期2018-07-16

產品代碼NFJ

諮詢委員會RA

決定相當於

器材摘要

Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System is the device name listed in this FDA 510(k) record. The listed applicant is Welch Allyn, Inc.. It received FDA 510(k) clearance on 2018-07-16 under 510(k) number K181016. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System?

Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System is a medical device that received FDA 510(k) clearance on 2018-07-16. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K181016.

When did Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System receive FDA 510(k) clearance?

Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System received FDA 510(k) clearance on 2018-07-16, under 510(k) number K181016.

Who is the listed applicant for Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System?

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

What is the FDA product code for Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System?

The FDA product code for Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System is NFJ.

其他以 Welch Allyn, Inc. 為申請人之記錄

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相關器械（代碼：NFJ）

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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