FDA 510(k)

Pioneer Elite 二极管激光器

K号: K181602 · 2019-09-10

决定日期2019-09-10

产品代码GEX

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决定实质等同

器械摘要

Pioneer Elite Diode Laser is the device name listed in this FDA 510(k) record. The listed applicant is CAO Group, Inc.. It received FDA 510(k) clearance on 2019-09-10 under 510(k) number K181602. 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 Pioneer Elite Diode Laser?

Pioneer Elite Diode Laser is a medical device that received FDA 510(k) clearance on 2019-09-10. The listed applicant is CAO Group, Inc.. The 510(k) number is K181602.

When did Pioneer Elite Diode Laser receive FDA 510(k) clearance?

Pioneer Elite Diode Laser received FDA 510(k) clearance on 2019-09-10, under 510(k) number K181602.

Who is the listed applicant for Pioneer Elite Diode Laser?

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

What is the FDA product code for Pioneer Elite Diode Laser?

The FDA product code for Pioneer Elite Diode Laser is GEX. This falls under the Gastroenterology category.

列明CAO Group, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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官方来源

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