FDA 510(k)

Insignis 皮下单針組

K 號：K202279 · 2021-08-13

決定日期2021-08-13

產品代碼FPA

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

Insignis Subcutaneous Needle Sets is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health Sciences, LLC. It received FDA 510(k) clearance on 2021-08-13 under 510(k) number K202279. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Insignis Subcutaneous Needle Sets?

Insignis Subcutaneous Needle Sets is a medical device that received FDA 510(k) clearance on 2021-08-13. The listed applicant is Innovative Health Sciences, LLC. The 510(k) number is K202279.

When did Insignis Subcutaneous Needle Sets receive FDA 510(k) clearance?

Insignis Subcutaneous Needle Sets received FDA 510(k) clearance on 2021-08-13, under 510(k) number K202279.

Who is the listed applicant for Insignis Subcutaneous Needle Sets?

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

What is the FDA product code for Insignis Subcutaneous Needle Sets?

The FDA product code for Insignis Subcutaneous Needle Sets is FPA.

其他以 Innovative 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。

K232328Insignis™ 靜脈注射系統

相關器械（代碼：FPA）

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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