H3+ 霍爾特記錄儀
K 號：K152626 · 2016-02-26
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器材摘要
H3+ Holter Recorder is the device name listed in this FDA 510(k) record. The listed applicant is Mortara Instrument, Inc.. It received FDA 510(k) clearance on 2016-02-26 under 510(k) number K152626. 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 H3+ Holter Recorder?
H3+ Holter Recorder is a medical device that received FDA 510(k) clearance on 2016-02-26. The listed applicant is Mortara Instrument, Inc.. The 510(k) number is K152626.
When did H3+ Holter Recorder receive FDA 510(k) clearance?
H3+ Holter Recorder received FDA 510(k) clearance on 2016-02-26, under 510(k) number K152626.
Who is the listed applicant for H3+ Holter Recorder?
The FDA 510(k) record lists Mortara Instrument, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for H3+ Holter Recorder?
The FDA product code for H3+ Holter Recorder is MWJ.
相關臨床試驗
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其他以 Mortara Instrument, Inc. 為申請人之記錄
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
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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