EPI K 控制台
K号: K172994 · 2017-10-26
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申请人Moria SA
决定日期2017-10-26
产品代码HNO
咨询委员会OP
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决定实质等同
器械摘要
EPI K Console is the device name listed in this FDA 510(k) record. The listed applicant is Moria SA. It received FDA 510(k) clearance on 2017-10-26 under 510(k) number K172994. The device is classified under product code HNO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the EPI K Console?
EPI K Console is a medical device that received FDA 510(k) clearance on 2017-10-26. The listed applicant is Moria SA. The 510(k) number is K172994.
When did EPI K Console receive FDA 510(k) clearance?
EPI K Console received FDA 510(k) clearance on 2017-10-26, under 510(k) number K172994.
Who is the listed applicant for EPI K Console?
The FDA 510(k) record lists Moria SA as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EPI K Console?
The FDA product code for EPI K Console is HNO.
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。
相关器械(代码:HNO)
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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