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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, electrical, evoked response
510(k) Number K900482
Device Name SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG
Original Applicant
AXON SYSTEMS, INC.
40-2 oser ave.
hauppauge,  NY  11788
Original Contact howard bailin
Regulation Number882.1870
Classification Product Code
GWF  
Date Received02/01/1990
Decision Date 06/20/1990
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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