si-Mochi 醫療設備規範文本翻譯： si-Mochi醫療設備，已通過FDA認證，符合510(k)規定，並獲得PMA許可。該設備的NCT編號為[識別號]，PMID編號為[識別號]。請參考以下URL獲取更多資訊：[URL]。
K 號：K202639 · 2021-04-21
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器材摘要
si-Mochi is the device name listed in this FDA 510(k) record. The listed applicant is Biostone, Ltd.. It received FDA 510(k) clearance on 2021-04-21 under 510(k) number K202639. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the si-Mochi?
si-Mochi is a medical device that received FDA 510(k) clearance on 2021-04-21. The listed applicant is Biostone, Ltd.. The 510(k) number is K202639.
When did si-Mochi receive FDA 510(k) clearance?
si-Mochi received FDA 510(k) clearance on 2021-04-21, under 510(k) number K202639.
Who is the listed applicant for si-Mochi?
The FDA 510(k) record lists Biostone, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for si-Mochi?
The FDA product code for si-Mochi is MQV.
相關臨床試驗
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相關器械（代碼：MQV）
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
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