低核心
K 號：K153162 · 2016-05-24
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器材摘要
Hypocore is the device name listed in this FDA 510(k) record. The listed applicant is Novocor Medical Systems, Inc.. It received FDA 510(k) clearance on 2016-05-24 under 510(k) number K153162. The device is classified under product code NCX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Hypocore?
Hypocore is a medical device that received FDA 510(k) clearance on 2016-05-24. The listed applicant is Novocor Medical Systems, Inc.. The 510(k) number is K153162.
When did Hypocore receive FDA 510(k) clearance?
Hypocore received FDA 510(k) clearance on 2016-05-24, under 510(k) number K153162.
Who is the listed applicant for Hypocore?
The FDA 510(k) record lists Novocor Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Hypocore?
The FDA product code for Hypocore is NCX.
相關臨床試驗
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相關器械（代碼：NCX）
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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