RTMsense 呼吸監測系統
K 號：K243183 · 2025-06-27
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器材摘要
RTMsense Respiratory Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Rtm Vital Signs, LLC. It received FDA 510(k) clearance on 2025-06-27 under 510(k) number K243183. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the RTMsense Respiratory Monitoring System?
RTMsense Respiratory Monitoring System is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is Rtm Vital Signs, LLC. The 510(k) number is K243183.
When did RTMsense Respiratory Monitoring System receive FDA 510(k) clearance?
RTMsense Respiratory Monitoring System received FDA 510(k) clearance on 2025-06-27, under 510(k) number K243183.
Who is the listed applicant for RTMsense Respiratory Monitoring System?
The FDA 510(k) record lists Rtm Vital Signs, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RTMsense Respiratory Monitoring System?
The FDA product code for RTMsense Respiratory Monitoring System is BZQ.
相關臨床試驗
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相關器械（代碼：BZQ）
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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