FDA 510(k)

Galaxy System

Número K: K223144 · 2023-03-01

Data da decisão2023-03-01

Código do produtoEOQ

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Galaxy System is the device name listed in this FDA 510(k) record. The listed applicant is Noah Medical Corp.. It received FDA 510(k) clearance on 2023-03-01 under 510(k) number K223144. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Galaxy System?

Galaxy System is a medical device that received FDA 510(k) clearance on 2023-03-01. The listed applicant is Noah Medical Corp.. The 510(k) number is K223144.

When did Galaxy System receive FDA 510(k) clearance?

Galaxy System received FDA 510(k) clearance on 2023-03-01, under 510(k) number K223144.

Who is the listed applicant for Galaxy System?

The FDA 510(k) record lists Noah Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Galaxy System?

The FDA product code for Galaxy System is EOQ.

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: EOQ)

K261637Single-use Flexible BronchoscopeHunan Vathin Medical Instrument Co., Ltd.K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S K2540263.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)Flexicare Medical Limited.K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation

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.