Lustre PRO 光系统
K号: K143713 · 2016-01-19
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决定日期2016-01-19
产品代码GEX
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
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器械摘要
Lustre PRO Light System is the device name listed in this FDA 510(k) record. The listed applicant is Ambicare Health, Ltd.. It received FDA 510(k) clearance on 2016-01-19 under 510(k) number K143713. 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 Lustre PRO Light System?
Lustre PRO Light System is a medical device that received FDA 510(k) clearance on 2016-01-19. The listed applicant is Ambicare Health, Ltd.. The 510(k) number is K143713.
When did Lustre PRO Light System receive FDA 510(k) clearance?
Lustre PRO Light System received FDA 510(k) clearance on 2016-01-19, under 510(k) number K143713.
Who is the listed applicant for Lustre PRO Light System?
The FDA 510(k) record lists Ambicare Health, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Lustre PRO Light System?
The FDA product code for Lustre PRO Light System is GEX. This falls under the Gastroenterology category.
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相关器械（代码：GEX）
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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