FDA 510(k)

FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)

Número K: K260270 · 2026-06-02

Data da decisão2026-06-02

Código do produtoCAF

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) is the device name listed in this FDA 510(k) record. The listed applicant is FindAir Sp. z o.o.. It received FDA 510(k) clearance on 2026-06-02 under 510(k) number K260270. 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 FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)?

FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) is a medical device that received FDA 510(k) clearance on 2026-06-02. The listed applicant is FindAir Sp. z o.o.. The 510(k) number is K260270.

When did FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) receive FDA 510(k) clearance?

FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) received FDA 510(k) clearance on 2026-06-02, under 510(k) number K260270.

Who is the listed applicant for FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)?

The FDA 510(k) record lists FindAir Sp. z o.o. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)?

The FDA product code for FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) 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

Dispositivos Relacionados (Código: CAF)

K254171Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)Shenzhen Mericonn Technology Co., Ltd.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.K250022HeroTracker SenseVoluntis

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.