FDA 510(k)

REST EAZY Appliance

Número K: K172760 · 2018-03-26

RequerenteInsert Molding Solutions, Inc.

Data da decisão2018-03-26

Código do produtoLRK

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

REST EAZY Appliance is the device name listed in this FDA 510(k) record. The listed applicant is Insert Molding Solutions, Inc.. It received FDA 510(k) clearance on 2018-03-26 under 510(k) number K172760. 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 REST EAZY Appliance?

REST EAZY Appliance is a medical device that received FDA 510(k) clearance on 2018-03-26. The listed applicant is Insert Molding Solutions, Inc.. The 510(k) number is K172760.

When did REST EAZY Appliance receive FDA 510(k) clearance?

REST EAZY Appliance received FDA 510(k) clearance on 2018-03-26, under 510(k) number K172760.

Who is the listed applicant for REST EAZY Appliance?

The FDA 510(k) record lists Insert Molding Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REST EAZY Appliance?

The FDA product code for REST EAZY Appliance 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: LRK)

K262104Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)Ram.Shaw Pte., Ltd.K261912SnØreNegatØrDnB Innovations, LLC K261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLC K261134Dormiva 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.