FDA 510(k)

ECHO雷射 X4

K 號：K181510 · 2018-09-04

決定日期2018-09-04

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

ECHOLASER X4 is the device name listed in this FDA 510(k) record. The listed applicant is El.En Electronic Engineering Spa. It received FDA 510(k) clearance on 2018-09-04 under 510(k) number K181510. 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 ECHOLASER X4？

ECHOLASER X4 is a medical device that received FDA 510(k) clearance on 2018-09-04. The listed applicant is El.En Electronic Engineering Spa. The 510(k) number is K181510.

ECHOLASER X4 當時是於何時獲得 FDA 510(k) 識別許可？

ECHOLASER X4 received FDA 510(k) clearance on 2018-09-04, under 510(k) number K181510.

誰是ECHOLASER X4的列名申請人？

The FDA 510(k) record lists El.En Electronic Engineering Spa as the applicant. This does not by itself establish the device manufacturer.

FDA產品代碼為何是 ECHOLASER X4？

FDA產品代碼為ECHOLASER X4的是GEX。這屬於內分泌學類別。

其他以 El.En Electronic Engineering Spa 為申請人之記錄

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