微氧2型OSA設備搭配微型錄音器
K 號：K161624 · 2016-11-07
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器材摘要
MicrO2 OSA Device with Micro-Recorder is the device name listed in this FDA 510(k) record. The listed applicant is Microdental, Inc.. It received FDA 510(k) clearance on 2016-11-07 under 510(k) number K161624. The device is classified under product code PLC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the MicrO2 OSA Device with Micro-Recorder?
MicrO2 OSA Device with Micro-Recorder is a medical device that received FDA 510(k) clearance on 2016-11-07. The listed applicant is Microdental, Inc.. The 510(k) number is K161624.
When did MicrO2 OSA Device with Micro-Recorder receive FDA 510(k) clearance?
MicrO2 OSA Device with Micro-Recorder received FDA 510(k) clearance on 2016-11-07, under 510(k) number K161624.
Who is the listed applicant for MicrO2 OSA Device with Micro-Recorder?
The FDA 510(k) record lists Microdental, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MicrO2 OSA Device with Micro-Recorder?
The FDA product code for MicrO2 OSA Device with Micro-Recorder is PLC.
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：PLC）
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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