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FDA 510(k)

精英生物醫學解決方案 計劃劑量請求纜線

K 號:K220695 · 2022-04-29

決定日期2022-04-29
產品代碼MRZ
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

Elite Biomedical Solutions Dose Request Cord is the device name listed in this FDA 510(k) record. The listed applicant is Elite Biomedical Solutions. It received FDA 510(k) clearance on 2022-04-29 under 510(k) number K220695. The device is classified under product code MRZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Elite Biomedical Solutions Dose Request Cord?

Elite Biomedical Solutions Dose Request Cord is a medical device that received FDA 510(k) clearance on 2022-04-29. The listed applicant is Elite Biomedical Solutions. The 510(k) number is K220695.

When did Elite Biomedical Solutions Dose Request Cord receive FDA 510(k) clearance?

Elite Biomedical Solutions Dose Request Cord received FDA 510(k) clearance on 2022-04-29, under 510(k) number K220695.

Who is the listed applicant for Elite Biomedical Solutions Dose Request Cord?

The FDA 510(k) record lists Elite Biomedical Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elite Biomedical Solutions Dose Request Cord?

The FDA product code for Elite Biomedical Solutions Dose Request Cord is MRZ.

相關臨床試驗

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相關器械(代碼:MRZ)

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。

官方來源

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