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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K854268
Device Name DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNER
Applicant
Del Mar Avionics
1621 Alton Pkwy.
Irvine,  CA  92606
Applicant Contact DAVID JOHNSON
Correspondent
Del Mar Avionics
1621 Alton Pkwy.
Irvine,  CA  92606
Correspondent Contact DAVID JOHNSON
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received10/23/1985
Decision Date 03/27/1986
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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