epoc 血尿素氮检测，epoc 总二氧化碳检测
K号: K171247 · 2018-01-17
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申请人Epocal, Inc.
决定日期2018-01-17
产品代码CDS
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
epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test is the device name listed in this FDA 510(k) record. The listed applicant is Epocal, Inc.. It received FDA 510(k) clearance on 2018-01-17 under 510(k) number K171247. The device is classified under product code CDS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test?
epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test is a medical device that received FDA 510(k) clearance on 2018-01-17. The listed applicant is Epocal, Inc.. The 510(k) number is K171247.
When did epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test receive FDA 510(k) clearance?
epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test received FDA 510(k) clearance on 2018-01-17, under 510(k) number K171247.
Who is the listed applicant for epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test?
The FDA 510(k) record lists Epocal, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test?
The FDA product code for epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test is CDS.
相关临床试验
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列明Epocal, 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。
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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