FDA 510(k)

Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer

Número K: K211800 · 2022-12-08

Data da decisão2022-12-08

Código do produtoLGZ

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer is the device name listed in this FDA 510(k) record. The listed applicant is Quality IN Flow , Ltd.. It received FDA 510(k) clearance on 2022-12-08 under 510(k) number K211800. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer?

Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer is a medical device that received FDA 510(k) clearance on 2022-12-08. The listed applicant is Quality IN Flow , Ltd.. The 510(k) number is K211800.

When did Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer receive FDA 510(k) clearance?

Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer received FDA 510(k) clearance on 2022-12-08, under 510(k) number K211800.

Who is the listed applicant for Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer?

The FDA 510(k) record lists Quality IN Flow , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer?

The FDA product code for Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer is LGZ.

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 Quality IN Flow , Ltd. como candidato(a)

K180154QiF Blood and Fluid Warmer K171215QiF Blood and Fluid Warmer K163708QiF Blood and Fluid Warmer K150404QiF Blood and Fluid Warmer

Dispositivos Relacionados (Código: LGZ)

K262532NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)ICU Medical K260988°M Warmer System with °M StationMequ A/S K252636Fluido Compact SystemThe Surgical Company International B.V.K251733Fluido® AirGuard SystemThe Surgical Company International BV (As Tsc Life)K232107°M Warmer SystemMequ A/S K211618Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V.

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.