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FDA 510(k)

Remvia 夜间护牙器

K号: K250743 · 2025-12-05

申请人Remvia
决定日期2025-12-05
产品代码MQC
决定实质等同

器械摘要

Remvia NightGuard is the device name listed in this FDA 510(k) record. The listed applicant is Remvia. It received FDA 510(k) clearance on 2025-12-05 under 510(k) number K250743. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

常见问题

What is the Remvia NightGuard?

Remvia NightGuard is a medical device that received FDA 510(k) clearance on 2025-12-05. The listed applicant is Remvia. The 510(k) number is K250743.

When did Remvia NightGuard receive FDA 510(k) clearance?

Remvia NightGuard received FDA 510(k) clearance on 2025-12-05, under 510(k) number K250743.

Who is the listed applicant for Remvia NightGuard?

The FDA 510(k) record lists Remvia as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Remvia NightGuard?

The FDA product code for Remvia NightGuard is MQC.

相关临床试验

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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

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