FDA 510(k)

Nouvo安全組合

K 號：K232234 · 2024-03-15

決定日期2024-03-15

產品代碼FOZ

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

Nouvo Safety Set is the device name listed in this FDA 510(k) record. The listed applicant is Poly Medicure Limited. It received FDA 510(k) clearance on 2024-03-15 under 510(k) number K232234. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Nouvo Safety Set?

Nouvo Safety Set is a medical device that received FDA 510(k) clearance on 2024-03-15. The listed applicant is Poly Medicure Limited. The 510(k) number is K232234.

When did Nouvo Safety Set receive FDA 510(k) clearance?

Nouvo Safety Set received FDA 510(k) clearance on 2024-03-15, under 510(k) number K232234.

Who is the listed applicant for Nouvo Safety Set?

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

What is the FDA product code for Nouvo Safety Set?

The FDA product code for Nouvo Safety Set is FOZ.

其他以 Poly Medicure Limited 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。

K252513Polywin 安全 (14G x 51mm；16G x 51mm；18G x 64mm；20G x 64mm；20G x 45mm；22G x 64mm；22G x 45mm；24G x 32mm；24G x 14mm，26G x 14mm)；Polywin 安全 Adva (20G x 45mm；22G x 64mm；22G x 45mm；24G x 32 mm；24G x 14mm；14G x 51mm；16G x 51mm；18G x 64mm；20G x 64mm，26G x 14mm)K252677多層保護安全I.V.針管 K231401多安全 BC，多安全 BC Adva，多威安安全，多威安安全 Adva K230616Polyguard及Polyshield安全I.V.針筒 K220312多融合靜脈注射輸液套組

相關器械（代碼：FOZ）

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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官方來源

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