FDA 510(k)

Intelligent Mesh Nebulizer

Número K: K171549 · 2018-08-31

RequerenteQingdao Future Medical Technology Co., Ltd.

Data da decisão2018-08-31

Código do produtoCAF

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Intelligent Mesh Nebulizer is the device name listed in this FDA 510(k) record. The listed applicant is Qingdao Future Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-08-31 under 510(k) number K171549. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Intelligent Mesh Nebulizer?

Intelligent Mesh Nebulizer is a medical device that received FDA 510(k) clearance on 2018-08-31. The listed applicant is Qingdao Future Medical Technology Co., Ltd.. The 510(k) number is K171549.

When did Intelligent Mesh Nebulizer receive FDA 510(k) clearance?

Intelligent Mesh Nebulizer received FDA 510(k) clearance on 2018-08-31, under 510(k) number K171549.

Who is the listed applicant for Intelligent Mesh Nebulizer?

The FDA 510(k) record lists Qingdao Future Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intelligent Mesh Nebulizer?

The FDA product code for Intelligent Mesh Nebulizer is CAF.

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

Outros registros que listam Qingdao Future Medical Technology Co., Ltd. como candidato(a)

K251659Mesh Nebulizer (H6)

Dispositivos Relacionados (Código: CAF)

K254171Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)Shenzhen Mericonn Technology Co., Ltd.K260270FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o.K251572eRapid with eTrack SystemPari Respiratory Equipment, Inc.K251659Mesh Nebulizer (H6)Qingdao Future Medical Technology Co., Ltd.K244035Portable mesh nebulizer (JM821)Shenzhen Jermei Medical Device Technology Co., Ltd.K243468Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)Joytech Healthcare Co. , Ltd.

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.