FDA 510(k)

EyeBOX (型號 EBX-4)

K 號：K212310 · 2021-12-22

決定日期2021-12-22

產品代碼QEA

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

EyeBOX (Model EBX-4) is the device name listed in this FDA 510(k) record. The listed applicant is Oculogica, Inc.. It received FDA 510(k) clearance on 2021-12-22 under 510(k) number K212310. The device is classified under product code QEA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EyeBOX (Model EBX-4)?

EyeBOX (Model EBX-4) is a medical device that received FDA 510(k) clearance on 2021-12-22. The listed applicant is Oculogica, Inc.. The 510(k) number is K212310.

When did EyeBOX (Model EBX-4) receive FDA 510(k) clearance?

EyeBOX (Model EBX-4) received FDA 510(k) clearance on 2021-12-22, under 510(k) number K212310.

Who is the listed applicant for EyeBOX (Model EBX-4)?

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

What is the FDA product code for EyeBOX (Model EBX-4)?

The FDA product code for EyeBOX (Model EBX-4) is QEA.

其他以 Oculogica, Inc. 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。

K254086眼盒快接 K242116眼盒 EBX-4.1 K201841眼盒 K191183眼盒

相關器械（代碼：QEA）

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。

K254086眼盒快接Oculogica, Inc.K242116眼盒 EBX-4.1Oculogica, Inc.K202927眼同調Syncthink, Inc.K201841眼盒Oculogica, Inc.K191183眼盒Oculogica, Inc.

官方來源

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