TRIUX™ neo (NM27000N)；MEGreview (SW26241N-B)
K号: K233985 · 2024-05-15
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申请人Megin OY
决定日期2024-05-15
产品代码OLX
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。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
TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) is the device name listed in this FDA 510(k) record. The listed applicant is Megin OY. It received FDA 510(k) clearance on 2024-05-15 under 510(k) number K233985. The device is classified under product code OLX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)?
TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) is a medical device that received FDA 510(k) clearance on 2024-05-15. The listed applicant is Megin OY. The 510(k) number is K233985.
When did TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) receive FDA 510(k) clearance?
TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) received FDA 510(k) clearance on 2024-05-15, under 510(k) number K233985.
Who is the listed applicant for TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)?
The FDA 510(k) record lists Megin OY as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)?
The FDA product code for TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B) is OLX.
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：OLX）
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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