FDA 510(k)

AdheResp Smart Breath-actuated Mesh Nebulizer

Número K: K250583 · 2025-06-20

Data da decisão2025-06-20

Código do produtoCAF

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

AdheResp Smart Breath-actuated Mesh Nebulizer is the device name listed in this FDA 510(k) record. The listed applicant is Hcmed Innovations Co., Ltd.. It received FDA 510(k) clearance on 2025-06-20 under 510(k) number K250583. 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 AdheResp Smart Breath-actuated Mesh Nebulizer?

AdheResp Smart Breath-actuated Mesh Nebulizer is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Hcmed Innovations Co., Ltd.. The 510(k) number is K250583.

When did AdheResp Smart Breath-actuated Mesh Nebulizer receive FDA 510(k) clearance?

AdheResp Smart Breath-actuated Mesh Nebulizer received FDA 510(k) clearance on 2025-06-20, under 510(k) number K250583.

Who is the listed applicant for AdheResp Smart Breath-actuated Mesh Nebulizer?

The FDA 510(k) record lists Hcmed Innovations Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AdheResp Smart Breath-actuated Mesh Nebulizer?

The FDA product code for AdheResp Smart Breath-actuated 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 Hcmed Innovations Co., Ltd. como candidato(a)

K202171Pulmogine Vibrating Mesh Nebulizer

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.