Elite iQ PRO (M122K1)
K号: K240396 · 2024-03-08
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器械摘要
Elite iQ PRO (M122K1) is the device name listed in this FDA 510(k) record. The listed applicant is Cynosure, LLC. It received FDA 510(k) clearance on 2024-03-08 under 510(k) number K240396. 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 Elite iQ PRO (M122K1)?
Elite iQ PRO (M122K1) is a medical device that received FDA 510(k) clearance on 2024-03-08. The listed applicant is Cynosure, LLC. The 510(k) number is K240396.
When did Elite iQ PRO (M122K1) receive FDA 510(k) clearance?
Elite iQ PRO (M122K1) received FDA 510(k) clearance on 2024-03-08, under 510(k) number K240396.
Who is the listed applicant for Elite iQ PRO (M122K1)?
The FDA 510(k) record lists Cynosure, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Elite iQ PRO (M122K1)?
The FDA product code for Elite iQ PRO (M122K1) is GEX. This falls under the Gastroenterology category.
相关临床试验
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列明Cynosure, LLC为申报人的其他记录
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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
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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