FDA 510(k)

Hudson RCI AquaPak Sterile Prefilled Nebulizers

Número K: K153010 · 2016-07-26

Data da decisão2016-07-26

Código do produtoCAF

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Hudson RCI AquaPak Sterile Prefilled Nebulizers is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2016-07-26 under 510(k) number K153010. 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 Hudson RCI AquaPak Sterile Prefilled Nebulizers?

Hudson RCI AquaPak Sterile Prefilled Nebulizers is a medical device that received FDA 510(k) clearance on 2016-07-26. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K153010.

When did Hudson RCI AquaPak Sterile Prefilled Nebulizers receive FDA 510(k) clearance?

Hudson RCI AquaPak Sterile Prefilled Nebulizers received FDA 510(k) clearance on 2016-07-26, under 510(k) number K153010.

Who is the listed applicant for Hudson RCI AquaPak Sterile Prefilled Nebulizers?

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

What is the FDA product code for Hudson RCI AquaPak Sterile Prefilled Nebulizers?

The FDA product code for Hudson RCI AquaPak Sterile Prefilled Nebulizers 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 Teleflexmedical, Inc. como candidato(a)

K232469Rüsch Latex Gold Foley Catheter K212077Teleflex Rusch SoftSimplastic Foley Catheters K192324Sheridan Spiral-Flex Endotracheal Tubes K182847Hudson RCI Voldyne Volumetric Exerciser K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter K183461Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter

Ver todos os 19 dispositivos →

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.