EPOCH 2000 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 Epoch 2000 Neurological Workstation.

Pre-market Notification Details

Device IDK971819
510k NumberK971819
Device Name:EPOCH 2000 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  
CFR Regulation Number882.1870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-16
Decision Date1997-11-20
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.