FDA 510(k)

REGER Nebulizer Irrigation Cannula

Número K: K231622 · 2023-09-29

Data da decisão2023-09-29

Código do produtoGCJ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

REGER Nebulizer Irrigation Cannula is the device name listed in this FDA 510(k) record. The listed applicant is Reger Medizintechnik, GmbH. It received FDA 510(k) clearance on 2023-09-29 under 510(k) number K231622. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the REGER Nebulizer Irrigation Cannula?

REGER Nebulizer Irrigation Cannula is a medical device that received FDA 510(k) clearance on 2023-09-29. The listed applicant is Reger Medizintechnik, GmbH. The 510(k) number is K231622.

When did REGER Nebulizer Irrigation Cannula receive FDA 510(k) clearance?

REGER Nebulizer Irrigation Cannula received FDA 510(k) clearance on 2023-09-29, under 510(k) number K231622.

Who is the listed applicant for REGER Nebulizer Irrigation Cannula?

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

What is the FDA product code for REGER Nebulizer Irrigation Cannula?

The FDA product code for REGER Nebulizer Irrigation Cannula is GCJ.

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: GCJ)

K262397CuratOR EX2742Eizo Corporation K260884UNIDRIVE Select SystemKarl Storz SE & CO. KG K260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony Corporation K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC K253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical Impact K261614LED LCD Monitor (OEV-271H)Lg Electronics.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.