VX130 眼科诊断设备
K号: K162067 · 2017-04-24
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申请人Luneau Sas
决定日期2017-04-24
产品代码HKX
咨询委员会OP
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决定实质等同
器械摘要
VX130 Ophthalmic Diagnostic Device is the device name listed in this FDA 510(k) record. The listed applicant is Luneau Sas. It received FDA 510(k) clearance on 2017-04-24 under 510(k) number K162067. The device is classified under product code HKX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the VX130 Ophthalmic Diagnostic Device?
VX130 Ophthalmic Diagnostic Device is a medical device that received FDA 510(k) clearance on 2017-04-24. The listed applicant is Luneau Sas. The 510(k) number is K162067.
When did VX130 Ophthalmic Diagnostic Device receive FDA 510(k) clearance?
VX130 Ophthalmic Diagnostic Device received FDA 510(k) clearance on 2017-04-24, under 510(k) number K162067.
Who is the listed applicant for VX130 Ophthalmic Diagnostic Device?
The FDA 510(k) record lists Luneau Sas as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VX130 Ophthalmic Diagnostic Device?
The FDA product code for VX130 Ophthalmic Diagnostic Device is HKX.
相关临床试验
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相关器械（代码：HKX）
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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