FDA 510(k)

Westmed Gas Sampling Cannula with O2 delivery

Número K: K162343 · 2016-12-14

Data da decisão2016-12-14

Código do produtoCCK

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Westmed Gas Sampling Cannula with O2 delivery is the device name listed in this FDA 510(k) record. The listed applicant is Westmed, Inc.. It received FDA 510(k) clearance on 2016-12-14 under 510(k) number K162343. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Westmed Gas Sampling Cannula with O2 delivery?

Westmed Gas Sampling Cannula with O2 delivery is a medical device that received FDA 510(k) clearance on 2016-12-14. The listed applicant is Westmed, Inc.. The 510(k) number is K162343.

When did Westmed Gas Sampling Cannula with O2 delivery receive FDA 510(k) clearance?

Westmed Gas Sampling Cannula with O2 delivery received FDA 510(k) clearance on 2016-12-14, under 510(k) number K162343.

Who is the listed applicant for Westmed Gas Sampling Cannula with O2 delivery?

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

What is the FDA product code for Westmed Gas Sampling Cannula with O2 delivery?

The FDA product code for Westmed Gas Sampling Cannula with O2 delivery is CCK.

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: CCK)

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden Corporation K261633VisuBreathAffirm Medical Technologies II, LLC K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC K250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden Corporation K251216Linha de Amostragem de CO2 0184; Linha de Amostragem de CO2 0184T; Linha de Amostragem de CO2 0139; Linha de Amostragem de CO2 0182Barbaras Development, Inc.

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.