FDA 510(k)

獨立角膜觀察室（IVC-21）

K 號：K211786 · 2021-12-03

決定日期2021-12-03

產品代碼LYX

決定相當於

器材摘要

Independent Corneal Viewing Chamber (IVC-21) is the device name listed in this FDA 510(k) record. The listed applicant is Bausch + Lomb, Incorporated. It received FDA 510(k) clearance on 2021-12-03 under 510(k) number K211786. The device is classified under product code LYX. FDA Decision: Substantially Equivalent.

常見問題

What is the Independent Corneal Viewing Chamber (IVC-21)?

Independent Corneal Viewing Chamber (IVC-21) is a medical device that received FDA 510(k) clearance on 2021-12-03. The listed applicant is Bausch + Lomb, Incorporated. The 510(k) number is K211786.

When did Independent Corneal Viewing Chamber (IVC-21) receive FDA 510(k) clearance?

Independent Corneal Viewing Chamber (IVC-21) received FDA 510(k) clearance on 2021-12-03, under 510(k) number K211786.

Who is the listed applicant for Independent Corneal Viewing Chamber (IVC-21)?

The FDA 510(k) record lists Bausch + Lomb, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Independent Corneal Viewing Chamber (IVC-21)?

The FDA product code for Independent Corneal Viewing Chamber (IVC-21) is LYX.

其他以 Bausch + Lomb, Incorporated 為申請人之記錄

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相關器械（代碼：LYX）

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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