醫用針刺系統 Dr. pen
K 號：K230420 · 2023-08-11
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決定日期2023-08-11
產品代碼QAI
諮詢委員會SU
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決定相當於
器材摘要
Dr. pen Microneedling System is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Ekai Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-08-11 under 510(k) number K230420. The device is classified under product code QAI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Dr. pen Microneedling System?
Dr. pen Microneedling System is a medical device that received FDA 510(k) clearance on 2023-08-11. The listed applicant is Guangzhou Ekai Electronic Technology Co., Ltd.. The 510(k) number is K230420.
When did Dr. pen Microneedling System receive FDA 510(k) clearance?
Dr. pen Microneedling System received FDA 510(k) clearance on 2023-08-11, under 510(k) number K230420.
Who is the listed applicant for Dr. pen Microneedling System?
The FDA 510(k) record lists Guangzhou Ekai Electronic Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Dr. pen Microneedling System?
The FDA product code for Dr. pen Microneedling System is QAI.
相關臨床試驗
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相關器械（代碼：QAI）
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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官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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