SmoothCool HR 系统
K号: K213484 · 2022-04-20
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决定日期2022-04-20
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。
决定实质等同
器械摘要
SmoothCool HR System is the device name listed in this FDA 510(k) record. The listed applicant is Jeisys Medical, Inc.. It received FDA 510(k) clearance on 2022-04-20 under 510(k) number K213484. 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 SmoothCool HR System?
SmoothCool HR System is a medical device that received FDA 510(k) clearance on 2022-04-20. The listed applicant is Jeisys Medical, Inc.. The 510(k) number is K213484.
When did SmoothCool HR System receive FDA 510(k) clearance?
SmoothCool HR System received FDA 510(k) clearance on 2022-04-20, under 510(k) number K213484.
Who is the listed applicant for SmoothCool HR System?
The FDA 510(k) record lists Jeisys Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SmoothCool HR System?
The FDA product code for SmoothCool HR System is GEX. This falls under the Gastroenterology category.
相关临床试验
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列明Jeisys Medical, 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。
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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