FDA 510(k)

MPowRx 수면주의 해결책 (Good Morning Snore Solution로도 알려짐)

K-번호: K193239 · 2020-01-03

신청자Mpowrx Health and Wellness Products 2012, Inc.

결정일2020-01-03

제품 코드LRK

자문 위원회의료 장비 규제 텍스트 번역 DE [회사명]의 [제품명]은 미국 식품의약국(FDA)에 등록된 의료 장비로, 510(k) 신청을 통해 승인을 받았습니다. 이 제품은 PMA(Premarket Approval)를 받지 않았으며, NCT(National Clinical Trial) 등록 번호는 [NCT 번호]입니다. PMID(Publication Medical Identifier)은 [PMID 번호]입니다. 더 자세한 정보는 다음 URL을 참조하세요: [URL]

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기기 요약

MPowRx Snoring Solution (also known as Good Morning Snore Solution) is the device name listed in this FDA 510(k) record. The listed applicant is Mpowrx Health and Wellness Products 2012, Inc.. It received FDA 510(k) clearance on 2020-01-03 under 510(k) number K193239. 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 MPowRx Snoring Solution (also known as Good Morning Snore Solution)?

MPowRx Snoring Solution (also known as Good Morning Snore Solution) is a medical device that received FDA 510(k) clearance on 2020-01-03. The listed applicant is Mpowrx Health and Wellness Products 2012, Inc.. The 510(k) number is K193239.

When did MPowRx Snoring Solution (also known as Good Morning Snore Solution) receive FDA 510(k) clearance?

MPowRx Snoring Solution (also known as Good Morning Snore Solution) received FDA 510(k) clearance on 2020-01-03, under 510(k) number K193239.

Who is the listed applicant for MPowRx Snoring Solution (also known as Good Morning Snore Solution)?

The FDA 510(k) record lists Mpowrx Health and Wellness Products 2012, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MPowRx Snoring Solution (also known as Good Morning Snore Solution)?

The FDA product code for MPowRx Snoring Solution (also known as Good Morning Snore Solution) is LRK.

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FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

MPowRx 수면주의 해결책 (Good Morning Snore Solution로도 알려짐)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: LRK)

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