FDA 510(k)

ATOVEN-可重复使用激光光纤

K号: K152667 · 2016-06-09

决定日期2016-06-09

产品代码GEX

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决定实质等同

器械摘要

ATOVEN-Reusable Laser Fiber is the device name listed in this FDA 510(k) record. The listed applicant is Diotech CO. It received FDA 510(k) clearance on 2016-06-09 under 510(k) number K152667. 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.

常见问题

What is the ATOVEN-Reusable Laser Fiber?

ATOVEN-Reusable Laser Fiber is a medical device that received FDA 510(k) clearance on 2016-06-09. The listed applicant is Diotech CO. The 510(k) number is K152667.

When did ATOVEN-Reusable Laser Fiber receive FDA 510(k) clearance?

ATOVEN-Reusable Laser Fiber received FDA 510(k) clearance on 2016-06-09, under 510(k) number K152667.

Who is the listed applicant for ATOVEN-Reusable Laser Fiber?

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

What is the FDA product code for ATOVEN-Reusable Laser Fiber?

The FDA product code for ATOVEN-Reusable Laser Fiber is GEX. This falls under the Gastroenterology category.

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ATOVEN-可重复使用激光光纤

器械摘要

常见问题

相关临床试验

相关器械（代码：GEX）

官方来源