Aviso: Este site agrega dados públicos oficiais da FDA, ClinicalTrials.gov, PubMed e SEC EDGAR apenas para referência geral. Não constitui aconselhamento médico, diagnóstico, recomendação de tratamento ou aconselhamento de investimento.

FDA 510(k)

MPowRx Snoring Solution (also known as Good Morning Snore Solution)

Número K: K193239 · 2020-01-03

RequerenteMpowrx Health and Wellness Products 2012, Inc.
Data da decisão2020-01-03
Código do produtoLRK
Comité consultivoDE
DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: LRK)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K262104Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)Ram.Shaw Pte., Ltd.K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLC

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.

↑