O-Scan
K号: K183685 · 2019-01-22
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器械摘要
O-Scan is the device name listed in this FDA 510(k) record. The listed applicant is Esaote, S.p.A.. It received FDA 510(k) clearance on 2019-01-22 under 510(k) number K183685. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the O-Scan?
O-Scan is a medical device that received FDA 510(k) clearance on 2019-01-22. The listed applicant is Esaote, S.p.A.. The 510(k) number is K183685.
When did O-Scan receive FDA 510(k) clearance?
O-Scan received FDA 510(k) clearance on 2019-01-22, under 510(k) number K183685.
Who is the listed applicant for O-Scan?
FDA 510(k)记录中列出Esaote, S.p.A.为申请人。这本身并不能确立该设备的制造商。
What is the FDA product code for O-Scan?
The FDA product code for O-Scan is LNH.
列明Esaote, S.p.A.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：LNH）
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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