FDA 510(k)

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K 號：K182318 · 2018-10-24

決定日期2018-10-24

產品代碼NFJ

諮詢委員會RA

決定相當於

器材摘要

Retina Workplace is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, Inc.. It received FDA 510(k) clearance on 2018-10-24 under 510(k) number K182318. 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 Retina Workplace?

Retina Workplace is a medical device that received FDA 510(k) clearance on 2018-10-24. The listed applicant is Carl Zeiss Meditec, Inc.. The 510(k) number is K182318.

When did Retina Workplace receive FDA 510(k) clearance?

Retina Workplace received FDA 510(k) clearance on 2018-10-24, under 510(k) number K182318.

Who is the listed applicant for Retina Workplace?

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

What is the FDA product code for Retina Workplace?

The FDA product code for Retina Workplace is NFJ.

其他以 Carl Zeiss Meditec, 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。

K260694蔡司臨床360Carl Zeiss Meditec, AG K253893Harmony參考系統搭配Harmony OCT檢視器（Octave）Topcon Healthcare Solutions EMEA Oy K234076iCare ALTIUS CWCentervue S.P.A.K232828IMAGEnet6 眼科數據系統Topcon Corporation K232944卡利斯多眼鏡Carl Zeiss Meditec, AG K232555和諧Topcon Healthcare Solutions

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