VibrantVue 角膜盐水
K号: K201069 · 2020-07-31
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决定日期2020-07-31
产品代码MRC
咨询委员会OP
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决定实质等同
器械摘要
VibrantVue Scleral Saline is the device name listed in this FDA 510(k) record. The listed applicant is Dry Eye Innovations, LLC. It received FDA 510(k) clearance on 2020-07-31 under 510(k) number K201069. The device is classified under product code MRC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the VibrantVue Scleral Saline?
VibrantVue Scleral Saline is a medical device that received FDA 510(k) clearance on 2020-07-31. The listed applicant is Dry Eye Innovations, LLC. The 510(k) number is K201069.
When did VibrantVue Scleral Saline receive FDA 510(k) clearance?
VibrantVue Scleral Saline received FDA 510(k) clearance on 2020-07-31, under 510(k) number K201069.
Who is the listed applicant for VibrantVue Scleral Saline?
The FDA 510(k) record lists Dry Eye Innovations, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VibrantVue Scleral Saline?
The FDA product code for VibrantVue Scleral Saline is MRC.
相关临床试验
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相关器械（代码：MRC）
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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