MiCor A100 腦波記錄器
K 號：K162665 · 2018-01-26
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器材摘要
MiCor A100 Wearable ECG Recorder is the device name listed in this FDA 510(k) record. The listed applicant is Mitac International Corp.. It received FDA 510(k) clearance on 2018-01-26 under 510(k) number K162665. 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 MiCor A100 Wearable ECG Recorder?
MiCor A100 Wearable ECG Recorder is a medical device that received FDA 510(k) clearance on 2018-01-26. The listed applicant is Mitac International Corp.. The 510(k) number is K162665.
When did MiCor A100 Wearable ECG Recorder receive FDA 510(k) clearance?
MiCor A100 Wearable ECG Recorder received FDA 510(k) clearance on 2018-01-26, under 510(k) number K162665.
Who is the listed applicant for MiCor A100 Wearable ECG Recorder?
The FDA 510(k) record lists Mitac International Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MiCor A100 Wearable ECG Recorder?
The FDA product code for MiCor A100 Wearable ECG Recorder 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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