Night Guard
K号: K202465 · 2020-11-25
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器械摘要
Night Guard is the device name listed in this FDA 510(k) record. The listed applicant is 3D Diagnostix, Inc.. It received FDA 510(k) clearance on 2020-11-25 under 510(k) number K202465. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.
常见问题
What is the Night Guard?
Night Guard is a medical device that received FDA 510(k) clearance on 2020-11-25. The listed applicant is 3D Diagnostix, Inc.. The 510(k) number is K202465.
When did Night Guard receive FDA 510(k) clearance?
Night Guard received FDA 510(k) clearance on 2020-11-25, under 510(k) number K202465.
Who is the listed applicant for Night Guard?
The FDA 510(k) record lists 3D Diagnostix, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Night Guard?
The FDA product code for Night Guard is MQC.
相关临床试验
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列明3D Diagnostix, Inc.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：MQC）
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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