安全心臟 Rx App
K 號：K251218 · 2026-02-06
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器材摘要
SafeBeat Rx App is the device name listed in this FDA 510(k) record. The listed applicant is SafeBeat Rx, Inc.. It received FDA 510(k) clearance on 2026-02-06 under 510(k) number K251218. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SafeBeat Rx App?
SafeBeat Rx App is a medical device that received FDA 510(k) clearance on 2026-02-06. The listed applicant is SafeBeat Rx, Inc.. The 510(k) number is K251218.
When did SafeBeat Rx App receive FDA 510(k) clearance?
SafeBeat Rx App received FDA 510(k) clearance on 2026-02-06, under 510(k) number K251218.
Who is the listed applicant for SafeBeat Rx App?
The FDA 510(k) record lists SafeBeat Rx, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SafeBeat Rx App?
The FDA product code for SafeBeat Rx App is DQK.
相關臨床試驗
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相關器械（代碼：DQK）
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。
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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