NEUROMARK System

Electrosurgical, Cutting & Coagulation & Accessories

Neurent Medical

The following data is part of a premarket notification filed by Neurent Medical with the FDA for Neuromark System.

Pre-market Notification Details

Device IDK222032
510k NumberK222032
Device Name:NEUROMARK System
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Neurent Medical 1 Oran Point, Main Street, Oranmore Galway,  IE H91D7X2
ContactKaren E. Peterson
CorrespondentKaren E. Peterson
Neurent Medical 1 Oran Point, Main Street, Oranmore Galway,  IE H91D7X2
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-11
Decision Date2022-10-26

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