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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Temperature Measurement, Direct Contact, Powered
510(k) Number K950986
Device Name NEUROREADER
Applicant
Artronics
464 Sweetbriar Way
Easley,  SC  29640
Applicant Contact ROBERT A TEAGUE
Correspondent
Artronics
464 Sweetbriar Way
Easley,  SC  29640
Correspondent Contact ROBERT A TEAGUE
Regulation Number882.1570
Classification Product Code
HCS  
Date Received03/03/1995
Decision Date 11/09/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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