FDA 510(k)星麗貼
K 號:K221589 · 2023-03-24
決定日期2023-03-24
產品代碼GXY
諮詢委員會NE
(請提供完整的英文描述,以便進行翻譯。)
決定相當於
器材摘要
Starly pad is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Xingyuanli Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-03-24 under 510(k) number K221589. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Starly pad?
Starly pad is a medical device that received FDA 510(k) clearance on 2023-03-24. The listed applicant is Shenzhen Xingyuanli Technology Co., Ltd.. The 510(k) number is K221589.
When did Starly pad receive FDA 510(k) clearance?
Starly pad received FDA 510(k) clearance on 2023-03-24, under 510(k) number K221589.
Who is the listed applicant for Starly pad?
The FDA 510(k) record lists Shenzhen Xingyuanli Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Starly pad?
The FDA product code for Starly pad is GXY.
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相關器械(代碼:GXY)
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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