SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG

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 Software & Hardware Addition To Sentinel-4 Eeg.

Pre-market Notification Details

Device IDK900482
510k NumberK900482
Device Name:SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG
ClassificationStimulator, Electrical, Evoked Response
Applicant AXON SYSTEMS, INC. 40-2 OSER AVE. Hauppauge,  NY  11788
ContactHoward Bailin
CorrespondentHoward Bailin
AXON SYSTEMS, INC. 40-2 OSER AVE. Hauppauge,  NY  11788
Product CodeGWF  
CFR Regulation Number882.1870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-01
Decision Date1990-06-20

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