FDA 510(k)

MiniBox +

Número K: K161295 · 2016-10-21

RequerentePulmone Advanced Medical Devices, Ltd.

Data da decisão2016-10-21

Código do produtoBZC

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

MiniBox + is the device name listed in this FDA 510(k) record. The listed applicant is Pulmone Advanced Medical Devices, Ltd.. It received FDA 510(k) clearance on 2016-10-21 under 510(k) number K161295. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MiniBox +?

MiniBox + is a medical device that received FDA 510(k) clearance on 2016-10-21. The listed applicant is Pulmone Advanced Medical Devices, Ltd.. The 510(k) number is K161295.

When did MiniBox + receive FDA 510(k) clearance?

MiniBox + received FDA 510(k) clearance on 2016-10-21, under 510(k) number K161295.

Who is the listed applicant for MiniBox +?

The FDA 510(k) record lists Pulmone Advanced Medical Devices, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MiniBox +?

The FDA product code for MiniBox + is BZC.

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: BZC)

K240293STSTechbopulm, Ltd.K183567Vyntus/SentrySuite Product LineVyaire Medical K190853Vyntus BODYVyaire Medical, Inc.K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CARTVyaire Medical, Inc.K162515COSMED K5 Wearable Metabolic TechnologyCosmed Srl

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.