EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION

Stimulator, Electrical, Evoked Response

AXON SYSTEMS, INC.

The following data is part of a premarket notification filed by Axon Systems, Inc. with the FDA for Epochxp Neurological Workstation,epochxp Lite Neurological Workstation.

Pre-market Notification Details

Device IDK032741
510k NumberK032741
Device Name:EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION
ClassificationStimulator, Electrical, Evoked Response
Applicant AXON SYSTEMS, INC. 400-2200 OSER AVE. Hauppauge,  NY  11788
ContactHoward Bailin
CorrespondentHoward Bailin
AXON SYSTEMS, INC. 400-2200 OSER AVE. Hauppauge,  NY  11788
Product CodeGWF  
Subsequent Product CodeGWE
Subsequent Product CodeGWJ
Subsequent Product CodeGWQ
Subsequent Product CodeOLT
CFR Regulation Number882.1870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-04
Decision Date2003-12-16
Summary:summary

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