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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Temperature Discrimination
510(k) Number K141208
Device Name DYNAMIC NEUROSCREENING DEVICE
Applicant
Prosenex
342 E. Main St.
Suite 207
Leola,  PA  17540
Applicant Contact WILLIAM G MCLAIN
Correspondent
Prosenex
342 E. Main St.
Suite 207
Leola,  PA  17540
Correspondent Contact WILLIAM G MCLAIN
Regulation Number882.1200
Classification Product Code
LQW  
Subsequent Product Code
LLN  
Date Received05/09/2014
Decision Date 07/23/2014
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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