MFUSE (MS001)
K 號：K250319 · 2025-12-15
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器材摘要
MFUSE (MS001) is the device name listed in this FDA 510(k) record. The listed applicant is Machina Medical, Inc.. It received FDA 510(k) clearance on 2025-12-15 under 510(k) number K250319. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.
常見問題
What is the MFUSE (MS001)?
MFUSE (MS001) is a medical device that received FDA 510(k) clearance on 2025-12-15. The listed applicant is Machina Medical, Inc.. The 510(k) number is K250319.
When did MFUSE (MS001) receive FDA 510(k) clearance?
MFUSE (MS001) received FDA 510(k) clearance on 2025-12-15, under 510(k) number K250319.
Who is the listed applicant for MFUSE (MS001)?
The FDA 510(k) record lists Machina Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MFUSE (MS001)?
The FDA product code for MFUSE (MS001) is QSY.
相關臨床試驗
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相關器械（代碼：QSY）
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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