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FDA 510(k)

醫療設備名稱:Amplatz 微插頭

K 號:K182944 · 2019-04-17

決定日期2019-04-17
產品代碼KRD
諮詢委員會履歷
決定相當於

器材摘要

Dr. Amplatz Micro Plug is the device name listed in this FDA 510(k) record. The listed applicant is Ka Medical, LLC. It received FDA 510(k) clearance on 2019-04-17 under 510(k) number K182944. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dr. Amplatz Micro Plug?

Dr. Amplatz Micro Plug is a medical device that received FDA 510(k) clearance on 2019-04-17. The listed applicant is Ka Medical, LLC. The 510(k) number is K182944.

When did Dr. Amplatz Micro Plug receive FDA 510(k) clearance?

Dr. Amplatz Micro Plug received FDA 510(k) clearance on 2019-04-17, under 510(k) number K182944.

Who is the listed applicant for Dr. Amplatz Micro Plug?

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

What is the FDA product code for Dr. Amplatz Micro Plug?

The FDA product code for Dr. Amplatz Micro Plug is KRD.

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相關器械(代碼:KRD)

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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