FDA 510(k)

gammaCore-S

K 號：K173442 · 2018-01-23

決定日期2018-01-23

產品代碼PKR

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

gammaCore-S is the device name listed in this FDA 510(k) record. The listed applicant is Electrocore, LLC. It received FDA 510(k) clearance on 2018-01-23 under 510(k) number K173442. 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-S?

gammaCore-S is a medical device that received FDA 510(k) clearance on 2018-01-23. The listed applicant is Electrocore, LLC. The 510(k) number is K173442.

When did gammaCore-S receive FDA 510(k) clearance?

gammaCore-S received FDA 510(k) clearance on 2018-01-23, under 510(k) number K173442.

Who is the listed applicant for gammaCore-S?

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-S?

The FDA product code for gammaCore-S is PKR.

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。

K180538gammaCore Sapphire K171306gammaCore-S

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。

K211856gammaCore SapphireElectrocore, Inc.K203546gammaCore SapphireElectrocore, Inc.K191830gammaCore SapphireElectrocore, Inc.K182369gammaCore SapphireElectrocore, Inc.K180538gammaCore SapphireElectrocore, LLC K172270gammaCore-2Eletrocore, LLC

官方來源

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