FDA 510(k)

Orchid 安全釋放閥TM

K 號：K232094 · 2023-10-03

決定日期2023-10-03

產品代碼QOI

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

Orchid Safety Release ValveTM is the device name listed in this FDA 510(k) record. The listed applicant is Linear Health Sciences, LLC. It received FDA 510(k) clearance on 2023-10-03 under 510(k) number K232094. The device is classified under product code QOI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Orchid Safety Release ValveTM?

Orchid Safety Release ValveTM is a medical device that received FDA 510(k) clearance on 2023-10-03. The listed applicant is Linear Health Sciences, LLC. The 510(k) number is K232094.

When did Orchid Safety Release ValveTM receive FDA 510(k) clearance?

Orchid Safety Release ValveTM received FDA 510(k) clearance on 2023-10-03, under 510(k) number K232094.

Who is the listed applicant for Orchid Safety Release ValveTM?

The FDA 510(k) record lists Linear Health Sciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Orchid Safety Release ValveTM?

The FDA product code for Orchid Safety Release ValveTM is QOI.

其他以 Linear Health Sciences, LLC 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。

K241415Orchid 安全釋放閥™K230266蘭花安全釋放閥 K212064蘭花安全釋放閥（TM）

相關器械（代碼：QOI）

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。

K241415Orchid 安全釋放閥™Linear Health Sciences, LLC K231957SafeBreak® 頸動脈血管Lineus Medical K223486SafeBreak® 頸動脈血管Lineus Medical K230266蘭花安全釋放閥Linear Health Sciences, LLC K222791SafeBreak 頸動脈Lineus Medical, LLC K212064蘭花安全釋放閥（TM）Linear Health Sciences, LLC

官方來源

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