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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplifier, Physiological Signal
510(k) Number K861014
Device Name AMPLAID MK15 (EVOKED POTENTIAL SYSTEM)
Applicant
AMPLAID USA, INC.
1225 CARNEGIE, UNIT 104
ROLLING MEADOWS,  IL  60008
Applicant Contact GIAN P MAZZONI
Correspondent
AMPLAID USA, INC.
1225 CARNEGIE, UNIT 104
ROLLING MEADOWS,  IL  60008
Correspondent Contact GIAN P MAZZONI
Regulation Number882.1835
Classification Product Code
GWL  
Date Received03/18/1986
Decision Date 08/20/1986
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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