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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Attention Task Performance
510(k) Number K141865
Device Name DANA
Applicant
Anthrotronix, Inc.
8737 Colesville Rd.
Suite L-203
Silver Spring,  MD  20910
Applicant Contact CORINA E LATHAN, PHD, PE
Correspondent
Anthrotronix, Inc.
8737 Colesville Rd.
Suite L-203
Silver Spring,  MD  20910
Correspondent Contact CORINA E LATHAN, PHD, PE
Classification Product Code
LQD  
Date Received07/10/2014
Decision Date 10/15/2014
Decision Substantially Equivalent (SESE)
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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