FDA 510(k)

TELIGEN System Peripheral Motor Nerve Stimulation Indications

Número K: K223438 · 2023-02-10

Data da decisão2023-02-10

Código do produtoPDQ

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

TELIGEN System Peripheral Motor Nerve Stimulation Indications is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2023-02-10 under 510(k) number K223438. The device is classified under product code PDQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TELIGEN System Peripheral Motor Nerve Stimulation Indications?

TELIGEN System Peripheral Motor Nerve Stimulation Indications is a medical device that received FDA 510(k) clearance on 2023-02-10. The listed applicant is Medos International SARL. The 510(k) number is K223438.

When did TELIGEN System Peripheral Motor Nerve Stimulation Indications receive FDA 510(k) clearance?

TELIGEN System Peripheral Motor Nerve Stimulation Indications received FDA 510(k) clearance on 2023-02-10, under 510(k) number K223438.

Who is the listed applicant for TELIGEN System Peripheral Motor Nerve Stimulation Indications?

The FDA 510(k) record lists Medos International SARL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TELIGEN System Peripheral Motor Nerve Stimulation Indications?

The FDA product code for TELIGEN System Peripheral Motor Nerve Stimulation Indications is PDQ.

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

Outros registros que listam Medos International SARL como candidato(a)

K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody K260240SYMPHONY Navigation Ready Instruments K253249TriALTIS™ Spine System K243249TriALTIS™ Spine System K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays K242042TriALTIS™ Spine System

Ver todos os 75 dispositivos →

Dispositivos Relacionados (Código: PDQ)

K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)Neuralytix K253580Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)Tedan Surgical Innovations K243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLC K221821Acessórios de Instrumentos IOM do ATECAlphatec Spine, Inc.K220160PediGuard ThreadedSpineguard S.A.K203684Neurosign V4 Intraoperative Nerve MonitorMagstim Company, Ltd.

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.