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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 -4801
Applicant Contact DAVID JOHNSON
Correspondent
DEL MAR AVIONICS
1621 ALTON PKWY.
IRVINE,  CA  92606 -4801
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
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