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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reduced- Montage Standard Electroencephalograph
510(k) Number K131944
Device Name IEEG
Applicant
Jordan Neuroscience, Inc.
1660 Plum Lane
Redlands,  CA  92374
Applicant Contact ANNE PERRY
Correspondent
Jordan Neuroscience, Inc.
1660 Plum Lane
Redlands,  CA  92374
Correspondent Contact ANNE PERRY
Regulation Number882.1400
Classification Product Code
OMC  
Date Received06/27/2013
Decision Date 04/10/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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