FDA 510(k)

Capnostream™35 Portable Respiratory Monitor (PM35MN)

Número K: K253030 · 2026-05-01

Data da decisão2026-05-01

Código do produtoCCK

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Capnostream™35 Portable Respiratory Monitor (PM35MN) is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2026-05-01 under 510(k) number K253030. 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 Capnostream™35 Portable Respiratory Monitor (PM35MN)?

Capnostream™35 Portable Respiratory Monitor (PM35MN) is a medical device that received FDA 510(k) clearance on 2026-05-01. The listed applicant is Covidien, LLC. The 510(k) number is K253030.

When did Capnostream™35 Portable Respiratory Monitor (PM35MN) receive FDA 510(k) clearance?

Capnostream™35 Portable Respiratory Monitor (PM35MN) received FDA 510(k) clearance on 2026-05-01, under 510(k) number K253030.

Who is the listed applicant for Capnostream™35 Portable Respiratory Monitor (PM35MN)?

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

What is the FDA product code for Capnostream™35 Portable Respiratory Monitor (PM35MN)?

The FDA product code for Capnostream™35 Portable Respiratory Monitor (PM35MN) 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

Outros registros que listam Covidien, LLC como candidato(a)

K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated K253527Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)K253984Instrument Exit Point on Touch Surgery™ Aide K251025Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)K251313Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLT K250725Hugo™ RAS System

Ver todos os 59 dispositivos →

Dispositivos Relacionados (Código: CCK)

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden Corporation K261633VisuBreathAffirm Medical Technologies II, 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.K240937AIM (N/A)Inventeur, LLC

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.