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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Spectrum, Electroencephalogram Signal
510(k) Number K803233
Device Name MEUROMETRICS MONITOR
Applicant
DADE MEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DADE MEDICAL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.1420
Classification Product Code
GWS  
Date Received12/22/1980
Decision Date 01/12/1981
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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