OT EQUATOR
K号: K160382 · 2016-08-11
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申请人Rhein'83 Srl
决定日期2016-08-11
产品代码NHA
咨询委员会DE
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决定实质等同
器械摘要
OT EQUATOR is the device name listed in this FDA 510(k) record. The listed applicant is Rhein'83 Srl. It received FDA 510(k) clearance on 2016-08-11 under 510(k) number K160382. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OT EQUATOR?
OT EQUATOR is a medical device that received FDA 510(k) clearance on 2016-08-11. The listed applicant is Rhein'83 Srl. The 510(k) number is K160382.
When did OT EQUATOR receive FDA 510(k) clearance?
OT EQUATOR received FDA 510(k) clearance on 2016-08-11, under 510(k) number K160382.
Who is the listed applicant for OT EQUATOR?
The FDA 510(k) record lists Rhein'83 Srl as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OT EQUATOR?
The FDA product code for OT EQUATOR is NHA.
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Rhein'83 Srl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：NHA）
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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