雲心臟週期變異™系統（100-01-001）
K 號：K241217 · 2025-01-16
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器材摘要
CloudHRV™ System (100-01-001) is the device name listed in this FDA 510(k) record. The listed applicant is Inmedix, Inc.. It received FDA 510(k) clearance on 2025-01-16 under 510(k) number K241217. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the CloudHRV™ System (100-01-001)?
CloudHRV™ System (100-01-001) is a medical device that received FDA 510(k) clearance on 2025-01-16. The listed applicant is Inmedix, Inc.. The 510(k) number is K241217.
When did CloudHRV™ System (100-01-001) receive FDA 510(k) clearance?
CloudHRV™ System (100-01-001) received FDA 510(k) clearance on 2025-01-16, under 510(k) number K241217.
Who is the listed applicant for CloudHRV™ System (100-01-001)?
The FDA 510(k) record lists Inmedix, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CloudHRV™ System (100-01-001)?
The FDA product code for CloudHRV™ System (100-01-001) is DPS.
相關臨床試驗
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相關器械（代碼：DPS）
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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