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FDA 510(k)

iLoop介入電線圈 0.55T

K 號:K241069 · 2024-06-07

決定日期2024-06-07
產品代碼MOS
諮詢委員會RA
決定相當於

器材摘要

iLoop Interventional Coil 0.55T is the device name listed in this FDA 510(k) record. The listed applicant is Noras Mri Products GmbH. It received FDA 510(k) clearance on 2024-06-07 under 510(k) number K241069. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the iLoop Interventional Coil 0.55T?

iLoop Interventional Coil 0.55T is a medical device that received FDA 510(k) clearance on 2024-06-07. The listed applicant is Noras Mri Products GmbH. The 510(k) number is K241069.

When did iLoop Interventional Coil 0.55T receive FDA 510(k) clearance?

iLoop Interventional Coil 0.55T received FDA 510(k) clearance on 2024-06-07, under 510(k) number K241069.

Who is the listed applicant for iLoop Interventional Coil 0.55T?

The FDA 510(k) record lists Noras Mri Products GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iLoop Interventional Coil 0.55T?

The FDA product code for iLoop Interventional Coil 0.55T is MOS.

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。

其他以 Noras Mri Products GmbH 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。

相關器械(代碼:MOS)

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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