輕鬆呼吸移動式呼吸監測器（MRM）
K 號：K211387 · 2021-11-23
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器材摘要
Breathe Easy Mobile Respiratory Monitor (MRM) is the device name listed in this FDA 510(k) record. The listed applicant is Sound Life Sciences, Inc.. It received FDA 510(k) clearance on 2021-11-23 under 510(k) number K211387. 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 Breathe Easy Mobile Respiratory Monitor (MRM)?
Breathe Easy Mobile Respiratory Monitor (MRM) is a medical device that received FDA 510(k) clearance on 2021-11-23. The listed applicant is Sound Life Sciences, Inc.. The 510(k) number is K211387.
When did Breathe Easy Mobile Respiratory Monitor (MRM) receive FDA 510(k) clearance?
Breathe Easy Mobile Respiratory Monitor (MRM) received FDA 510(k) clearance on 2021-11-23, under 510(k) number K211387.
Who is the listed applicant for Breathe Easy Mobile Respiratory Monitor (MRM)?
The FDA 510(k) record lists Sound Life Sciences, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Breathe Easy Mobile Respiratory Monitor (MRM)?
The FDA product code for Breathe Easy Mobile Respiratory Monitor (MRM) 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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