FDA 510(k)

AquaA

Número K: K213507 · 2022-07-27

RequerenteFresenius Medical Care Rental Therapies Group, LLC

Data da decisão2022-07-27

Código do produtoFIP

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

AquaA is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care Rental Therapies Group, LLC. It received FDA 510(k) clearance on 2022-07-27 under 510(k) number K213507. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AquaA?

AquaA is a medical device that received FDA 510(k) clearance on 2022-07-27. The listed applicant is Fresenius Medical Care Rental Therapies Group, LLC. The 510(k) number is K213507.

When did AquaA receive FDA 510(k) clearance?

AquaA received FDA 510(k) clearance on 2022-07-27, under 510(k) number K213507.

Who is the listed applicant for AquaA?

The FDA 510(k) record lists Fresenius Medical Care Rental Therapies Group, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AquaA?

The FDA product code for AquaA is FIP.

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: FIP)

K250471AquaC UNO HFresenius Medical Care Renal Therapies Group, LLC K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC K252181AquaAFresenius Medical Care North America K250514UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc.K232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLC K223479AQUAbase nXB.Braun Medical, 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.