FDA 510(k)

神經消融系統

K 號：K172881 · 2017-10-20

決定日期2017-10-20

產品代碼GEX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

NeuroBlate System is the device name listed in this FDA 510(k) record. The listed applicant is Monteris Medical,. It received FDA 510(k) clearance on 2017-10-20 under 510(k) number K172881. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

什么是NeuroBlate系統？

NeuroBlate System is a medical device that received FDA 510(k) clearance on 2017-10-20. The listed applicant is Monteris Medical,. The 510(k) number is K172881.

NeuroBlate System於何時獲得FDA 510(k)許可？

NeuroBlate System received FDA 510(k) clearance on 2017-10-20, under 510(k) number K172881.

誰是NeuroBlate系統的列名申請人？

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

FDA產品代碼是什麼？NeuroBlate System的FDA產品代碼是什麼？

The FDA product code for NeuroBlate System is GEX. This falls under the Gastroenterology category.

其他以 Monteris Medical, 為申請人之記錄

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