FDA 510(k)

OMNI外科系統

K 號：K173332 · 2017-12-21

決定日期2017-12-21

產品代碼MRH

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

OMNI Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Sight Sciences, Inc.. It received FDA 510(k) clearance on 2017-12-21 under 510(k) number K173332. The device is classified under product code MRH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OMNI Surgical System?

OMNI Surgical System is a medical device that received FDA 510(k) clearance on 2017-12-21. The listed applicant is Sight Sciences, Inc.. The 510(k) number is K173332.

When did OMNI Surgical System receive FDA 510(k) clearance?

OMNI Surgical System received FDA 510(k) clearance on 2017-12-21, under 510(k) number K173332.

Who is the listed applicant for OMNI Surgical System?

FDA 510(k) 記錄將 Sight Sciences, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for OMNI Surgical System?

The FDA product code for OMNI Surgical System is MRH.

其他以 Sight Sciences, 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。

K262479TearCare系統 K253760OMNI超級外科系統（1-110）K252409TearCare MGX 系統 K242786TearCare MGX 系統 K231084TearCare MGX 系統 K232214OMNI外科系統

查看所有 11 項裝置 →

相關器械（代碼：MRH）

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。

K253760OMNI超級外科系統（1-110）Sight Sciences, Inc.K243503VIA360™手術系統New World Medical, Inc.K232214OMNI外科系統Sight Sciences, Inc.K213173TrabEx ProMicrosurgical Technologies, Inc.K212797iPrime 粘度輸送系統Glaukos K211680Streamline外科系統New World Medical, Inc.

官方來源

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