GEM Premier 7000 with IQM3
K号: K223608 · 2023-08-10
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决定日期2023-08-10
产品代码CHL
咨询委员会CH
请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
GEM Premier 7000 with IQM3 is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory Company. It received FDA 510(k) clearance on 2023-08-10 under 510(k) number K223608. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the GEM Premier 7000 with IQM3?
GEM Premier 7000 with IQM3 is a medical device that received FDA 510(k) clearance on 2023-08-10. The listed applicant is Instrumentation Laboratory Company. The 510(k) number is K223608.
When did GEM Premier 7000 with IQM3 receive FDA 510(k) clearance?
GEM Premier 7000 with IQM3 received FDA 510(k) clearance on 2023-08-10, under 510(k) number K223608.
Who is the listed applicant for GEM Premier 7000 with IQM3?
The FDA 510(k) record lists Instrumentation Laboratory Company as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GEM Premier 7000 with IQM3?
The FDA product code for GEM Premier 7000 with IQM3 is CHL.
相关临床试验
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。
列明Instrumentation Laboratory Company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：CHL）
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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