Aviso: Este site agrega dados públicos oficiais da FDA, ClinicalTrials.gov, PubMed e SEC EDGAR apenas para referência geral. Não constitui aconselhamento médico, diagnóstico, recomendação de tratamento ou aconselhamento de investimento.

FDA 510(k)

Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K

Número K: K220177 · 2022-09-01

RequerenteMagnus Medical, Inc.
Data da decisão2022-09-01
Código do produtoOBP
Comité consultivoNE
DecisãoSubstantially Equivalent

Resumo do dispositivo

Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K is the device name listed in this FDA 510(k) record. The listed applicant is Magnus Medical, Inc.. It received FDA 510(k) clearance on 2022-09-01 under 510(k) number K220177. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K?

Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K is a medical device that received FDA 510(k) clearance on 2022-09-01. The listed applicant is Magnus Medical, Inc.. The 510(k) number is K220177.

When did Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K receive FDA 510(k) clearance?

Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K received FDA 510(k) clearance on 2022-09-01, under 510(k) number K220177.

Who is the listed applicant for Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K?

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

What is the FDA product code for Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K?

The FDA product code for Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K is OBP.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: OBP)

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.

K260396KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)Fidelity BioPharma Co.K260691BTL-699BTL Industries, Inc.K261228QuickVision Ultimate rTMSBrain Ultimate, Inc.K260189MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/SK260560Sistema de Terapia TMS Apollo; Sistema de Terapia TMS Apollo lightMag & More GmbHK252358Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim Oyj

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.

↑