gammaCore Sapphire
K 號：K180538 · 2018-03-30
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器材摘要
gammaCore Sapphire is the device name listed in this FDA 510(k) record. The listed applicant is Electrocore, LLC. It received FDA 510(k) clearance on 2018-03-30 under 510(k) number K180538. The device is classified under product code PKR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the gammaCore Sapphire?
gammaCore Sapphire is a medical device that received FDA 510(k) clearance on 2018-03-30. The listed applicant is Electrocore, LLC. The 510(k) number is K180538.
When did gammaCore Sapphire receive FDA 510(k) clearance?
gammaCore Sapphire received FDA 510(k) clearance on 2018-03-30, under 510(k) number K180538.
Who is the listed applicant for gammaCore Sapphire?
The FDA 510(k) record lists Electrocore, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for gammaCore Sapphire?
The FDA product code for gammaCore Sapphire is PKR.
相關臨床試驗
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其他以 Electrocore, LLC 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：PKR）
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。
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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