Leaseir MHR Xcell
K号: K214049 · 2022-06-02
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决定日期2022-06-02
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
Leaseir MHR Xcell is the device name listed in this FDA 510(k) record. The listed applicant is Leaseir Technologies, Slu. It received FDA 510(k) clearance on 2022-06-02 under 510(k) number K214049. 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 Leaseir MHR Xcell?
Leaseir MHR Xcell is a medical device that received FDA 510(k) clearance on 2022-06-02. The listed applicant is Leaseir Technologies, Slu. The 510(k) number is K214049.
When did Leaseir MHR Xcell receive FDA 510(k) clearance?
Leaseir MHR Xcell received FDA 510(k) clearance on 2022-06-02, under 510(k) number K214049.
Who is the listed applicant for Leaseir MHR Xcell?
The FDA 510(k) record lists Leaseir Technologies, Slu as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Leaseir MHR Xcell?
The FDA product code for Leaseir MHR Xcell is GEX. This falls under the Gastroenterology category.
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列明Leaseir Technologies, Slu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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