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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, photic, evoked response
510(K) Number K120104
Device Name VISIONSEARCH 1
Applicant
VISIONSEARCH PTY LTD
460 pacific highway
suite 408
st leonards, 
Contact arthur brandwood
Regulation Number882.1890
Classification Product Code
GWE  
Date Received01/13/2012
Decision Date 05/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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