NR錄音器
K 號：K161062 · 2016-06-13
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器材摘要
NR Recorder is the device name listed in this FDA 510(k) record. The listed applicant is Norav Medical GmbH. It received FDA 510(k) clearance on 2016-06-13 under 510(k) number K161062. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the NR Recorder?
NR Recorder is a medical device that received FDA 510(k) clearance on 2016-06-13. The listed applicant is Norav Medical GmbH. The 510(k) number is K161062.
When did NR Recorder receive FDA 510(k) clearance?
NR Recorder received FDA 510(k) clearance on 2016-06-13, under 510(k) number K161062.
Who is the listed applicant for NR Recorder?
The FDA 510(k) record lists Norav Medical GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NR Recorder?
The FDA product code for NR Recorder is MWJ.
相關臨床試驗
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。
相關器械（代碼：MWJ）
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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