Insight红外视频眼镜
K号: K203082 · 2020-11-12
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决定日期2020-11-12
产品代码GWN
咨询委员会NE
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器械摘要
Insight Infrared Video Goggles is the device name listed in this FDA 510(k) record. The listed applicant is Vestibular First. It received FDA 510(k) clearance on 2020-11-12 under 510(k) number K203082. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Insight Infrared Video Goggles?
Insight Infrared Video Goggles is a medical device that received FDA 510(k) clearance on 2020-11-12. The listed applicant is Vestibular First. The 510(k) number is K203082.
When did Insight Infrared Video Goggles receive FDA 510(k) clearance?
Insight Infrared Video Goggles received FDA 510(k) clearance on 2020-11-12, under 510(k) number K203082.
Who is the listed applicant for Insight Infrared Video Goggles?
The FDA 510(k) record lists Vestibular First as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Insight Infrared Video Goggles?
The FDA product code for Insight Infrared Video Goggles is GWN.
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相关器械（代码：GWN）
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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