FDA 510(k)

眼同調

K 號：K202927 · 2021-10-02

決定日期2021-10-02

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

EYE-SYNC is the device name listed in this FDA 510(k) record. The listed applicant is Syncthink, Inc.. It received FDA 510(k) clearance on 2021-10-02 under 510(k) number K202927. 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 EYE-SYNC?

EYE-SYNC is a medical device that received FDA 510(k) clearance on 2021-10-02. The listed applicant is Syncthink, Inc.. The 510(k) number is K202927.

When did EYE-SYNC receive FDA 510(k) clearance?

EYE-SYNC received FDA 510(k) clearance on 2021-10-02, under 510(k) number K202927.

Who is the listed applicant for EYE-SYNC?

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

What is the FDA product code for EYE-SYNC?

The FDA product code for EYE-SYNC is QEA.

其他以 Syncthink, 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。

K152915眼同調

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。

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官方來源

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