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FDA 510(k)

Synapsys Ulmer 鋸齒顫動攝影儀

K 號:K163558 · 2017-03-23

申請人Synapsys SA
決定日期2017-03-23
產品代碼GWN
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

Synapsys Ulmer Video Nystagmograph is the device name listed in this FDA 510(k) record. The listed applicant is Synapsys SA. It received FDA 510(k) clearance on 2017-03-23 under 510(k) number K163558. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Synapsys Ulmer Video Nystagmograph?

Synapsys Ulmer Video Nystagmograph is a medical device that received FDA 510(k) clearance on 2017-03-23. The listed applicant is Synapsys SA. The 510(k) number is K163558.

When did Synapsys Ulmer Video Nystagmograph receive FDA 510(k) clearance?

Synapsys Ulmer Video Nystagmograph received FDA 510(k) clearance on 2017-03-23, under 510(k) number K163558.

Who is the listed applicant for Synapsys Ulmer Video Nystagmograph?

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

What is the FDA product code for Synapsys Ulmer Video Nystagmograph?

The FDA product code for Synapsys Ulmer Video Nystagmograph is GWN.

相關臨床試驗

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相關器械(代碼:GWN)

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。

官方來源

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