FDA 510(k)

Nerivio, FGD000075-4.7

K 號：K203181 · 2021-01-22

決定日期2021-01-22

產品代碼QGT

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

Nerivio, FGD000075-4.7 is the device name listed in this FDA 510(k) record. The listed applicant is Theranica Bioelectronics , Ltd.. It received FDA 510(k) clearance on 2021-01-22 under 510(k) number K203181. The device is classified under product code QGT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Nerivio, FGD000075-4.7?

Nerivio, FGD000075-4.7 is a medical device that received FDA 510(k) clearance on 2021-01-22. The listed applicant is Theranica Bioelectronics , Ltd.. The 510(k) number is K203181.

When did Nerivio, FGD000075-4.7 receive FDA 510(k) clearance?

Nerivio, FGD000075-4.7 received FDA 510(k) clearance on 2021-01-22, under 510(k) number K203181.

Who is the listed applicant for Nerivio, FGD000075-4.7?

The FDA 510(k) record lists Theranica Bioelectronics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nerivio, FGD000075-4.7?

The FDA product code for Nerivio, FGD000075-4.7 is QGT.

其他以 Theranica Bioelectronics , Ltd. 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。

K232152NerivioInfinity K223169內瑞維歐

相關器械（代碼：QGT）

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。

K250405Nerivio；Nerivio InfinityTheranica Bio-Electronics, Ltd.K241756Nerivio; NerivioInfinityTheranica Bio-Electronics, Ltd.K232152NerivioInfinityTheranica Bioelectronics , Ltd.K223169內瑞維歐Theranica Bioelectronics , Ltd.K201824內瑞維歐Theranica Bio-Electronics, Ltd.

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。