FDA 510(k)

Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)

K-번호: K252531 · 2026-03-02

결정일2026-03-02

제품 코드LRK

자문 위원회DE

결정Substantially Equivalent

기기 요약

Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) is the device name listed in this FDA 510(k) record. The listed applicant is Myofunctional Research Co.. It received FDA 510(k) clearance on 2026-03-02 under 510(k) number K252531. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)?

Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) is a medical device that received FDA 510(k) clearance on 2026-03-02. The listed applicant is Myofunctional Research Co.. The 510(k) number is K252531.

When did Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) receive FDA 510(k) clearance?

Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) received FDA 510(k) clearance on 2026-03-02, under 510(k) number K252531.

Who is the listed applicant for Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)?

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

What is the FDA product code for Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)?

The FDA product code for Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) is LRK.

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Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: LRK)

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