FDA 510(k)

波光 FS200 患者介面

K 號：K190392 · 2019-03-26

決定日期2019-03-26

產品代碼GEX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

WaveLight FS200 Patient Interface is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Laboratories, Inc.. It received FDA 510(k) clearance on 2019-03-26 under 510(k) number K190392. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the WaveLight FS200 Patient Interface?

WaveLight FS200 Patient Interface is a medical device that received FDA 510(k) clearance on 2019-03-26. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K190392.

When did WaveLight FS200 Patient Interface receive FDA 510(k) clearance?

WaveLight FS200 Patient Interface received FDA 510(k) clearance on 2019-03-26, under 510(k) number K190392.

Who is the listed applicant for WaveLight FS200 Patient Interface?

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

What is the FDA product code for WaveLight FS200 Patient Interface?

The FDA product code for WaveLight FS200 Patient Interface is GEX. This falls under the Gastroenterology category.

其他以 Alcon Laboratories, Inc. 為申請人之記錄

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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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