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FDA 510(k)

Halo II 運動輸液系統（亦稱為Nimbus II 運動輸液系統、EVAA 運動輸液系統）

K 號：K153193 · 2016-08-30

申請人Zyno Medical, LLC
決定日期2016-08-30
產品代碼FRN
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

Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) is the device name listed in this FDA 510(k) record. The listed applicant is Zyno Medical, LLC. It received FDA 510(k) clearance on 2016-08-30 under 510(k) number K153193. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)?

Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) is a medical device that received FDA 510(k) clearance on 2016-08-30. The listed applicant is Zyno Medical, LLC. The 510(k) number is K153193.

When did Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) receive FDA 510(k) clearance?

Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) received FDA 510(k) clearance on 2016-08-30, under 510(k) number K153193.

Who is the listed applicant for Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)?

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

What is the FDA product code for Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)?

The FDA product code for Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) is FRN.

相關臨床試驗

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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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