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FDA 510(k)

Remvia NightGuard

K-Number: K250743 · 2025-12-05

ApplicantRemvia
Decision Date2025-12-05
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

Remvia NightGuard is a medical device manufactured by Remvia. It received FDA 510(k) clearance on 2025-12-05 under approval number K250743. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Remvia NightGuard?

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

When was Remvia NightGuard approved by the FDA?

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

What company makes Remvia NightGuard?

Remvia NightGuard is manufactured by Remvia.

What is the FDA product code for Remvia NightGuard?

The FDA product code for Remvia NightGuard is MQC.

Related Devices (Code: MQC)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.