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FDA 510(k)

Respiratory Muscle Trainer

K-Number: K240959 · 2024-12-18

Decision Date2024-12-18
Product CodeBYI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Respiratory Muscle Trainer is a medical device manufactured by Chongqing Moffy Innovation Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-12-18 under approval number K240959. The device is classified under product code BYI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Respiratory Muscle Trainer?

Respiratory Muscle Trainer is a medical device that received FDA 510(k) clearance on 2024-12-18. It is manufactured by Chongqing Moffy Innovation Technology Co., Ltd.. The 510(k) number is K240959.

When was Respiratory Muscle Trainer approved by the FDA?

Respiratory Muscle Trainer received FDA 510(k) clearance on 2024-12-18, under approval number K240959.

What company makes Respiratory Muscle Trainer?

Respiratory Muscle Trainer is manufactured by Chongqing Moffy Innovation Technology Co., Ltd..

What is the FDA product code for Respiratory Muscle Trainer?

The FDA product code for Respiratory Muscle Trainer is BYI.

Related Clinical Trials

Other Devices by Chongqing Moffy Innovation Technology Co., Ltd.

Related Devices (Code: BYI)

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.