FDA 510(k)

Assert-IQ (DM5100)

K 號：K253516 · 2025-12-18

決定日期2025-12-18

產品代碼MXD

諮詢委員會履歷

決定相當於

器材摘要

Assert-IQ (DM5100) is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2025-12-18 under 510(k) number K253516. The device is classified under product code MXD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Assert-IQ (DM5100)?

Assert-IQ (DM5100) is a medical device that received FDA 510(k) clearance on 2025-12-18. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K253516.

When did Assert-IQ (DM5100) receive FDA 510(k) clearance?

Assert-IQ (DM5100) received FDA 510(k) clearance on 2025-12-18, under 510(k) number K253516.

Who is the listed applicant for Assert-IQ (DM5100)?

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

What is the FDA product code for Assert-IQ (DM5100)?

The FDA product code for Assert-IQ (DM5100) is MXD.

其他以 ABBOTT MEDICAL 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。

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相關器械（代碼：MXD）

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。

K262735LINQ II 可植入式心臟監護器 (ICM) (LNQ22)Medtronic, Inc.K261074BIOMONITOR IV (471155)Biotronik, Inc.K251221Assert-IQ (DM5000)；Assert-IQ (DM5300)；Assert-IQ (DM5500)；Merlin.net (MN7000)Abbott K252593LUX-Dx II 可植入式心臟監護器（M302）；LUX-Dx II+ 可植入式心臟監護器（M312）Boston Scientific Corporation K240693LINQ II™ 可植入式心臟監護器 (ICM)Medtronic, Inc.K233562LINQ II 可植入式心臟監護器Medtronic, Inc.

官方來源

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