FDA 510(k)

O2asis Personal Oxygen Humidifier

Número K: K193411 · 2020-11-12

Data da decisão2020-11-12

Código do produtoBTT

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

O2asis Personal Oxygen Humidifier is the device name listed in this FDA 510(k) record. The listed applicant is Perma Pure, LLC. It received FDA 510(k) clearance on 2020-11-12 under 510(k) number K193411. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the O2asis Personal Oxygen Humidifier?

O2asis Personal Oxygen Humidifier is a medical device that received FDA 510(k) clearance on 2020-11-12. The listed applicant is Perma Pure, LLC. The 510(k) number is K193411.

When did O2asis Personal Oxygen Humidifier receive FDA 510(k) clearance?

O2asis Personal Oxygen Humidifier received FDA 510(k) clearance on 2020-11-12, under 510(k) number K193411.

Who is the listed applicant for O2asis Personal Oxygen Humidifier?

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

What is the FDA product code for O2asis Personal Oxygen Humidifier?

The FDA product code for O2asis Personal Oxygen Humidifier is BTT.

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: BTT)

K262268Optiflow Oxygen Kit (AA484J)Fisher and Paykel Healthcare Limited K254078HVT 2.0Vapotherm, Inc.K251448FL-10000U Respiratory HumidifierFlexicare Medical Limited.K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V.K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra SmallMedline Industries, LP

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.