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FDA 510(k)

迷你美Quick-Set® 迷你美Sure-T® 迷你美Silhouette® 迷你美Mio®

K 號：K160648 · 2016-08-10

申請人Unomedical A/S
決定日期2016-08-10
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

MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® is the device name listed in this FDA 510(k) record. The listed applicant is Unomedical A/S. It received FDA 510(k) clearance on 2016-08-10 under 510(k) number K160648. 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 MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®?

MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® is a medical device that received FDA 510(k) clearance on 2016-08-10. The listed applicant is Unomedical A/S. The 510(k) number is K160648.

When did MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® receive FDA 510(k) clearance?

MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® received FDA 510(k) clearance on 2016-08-10, under 510(k) number K160648.

Who is the listed applicant for MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®?

The FDA 510(k) record lists Unomedical A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®?

The FDA product code for MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® is FPA.

相關臨床試驗

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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其他以 Unomedical A/S 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。

K210544美敦力延長輸液針頭K192647neria guard 靜脈輸液針頭K173879迷你美迪 Mio 先進輸液組K162812Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set

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。

K254123Ecomed 一次性注射用藥物輸注套件Ecomed Solutions, LLCK261530iiSure 靜脈輸注套件Deka Research and DevelopmentK252543AMSafe 藥物輸注套件 (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath 火飛無針連接器 IT (9005)Puracath Medical, Inc.K251257nSet+ 稳定組 [6426733]; nSet+ 稳定組搭配 nSyte 非針刺連接器 (NFC) [6426731]; nSyte 非針刺連接器 (NFC) [6426727]Np MedicalK250325BD Alaris 泵輸注套件Carefusion (Bd)

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