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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Normalizing Quantitative Electroencephalograph Software
510(k) Number K952347
Device Name A-1050 EEG MONITOR
Applicant
Aspect Medical Systems, Inc.
2 Vision Dr.
Natick,  MA  01760 -2059
Applicant Contact M. CHRISTINE MORGIDA
Correspondent
Aspect Medical Systems, Inc.
2 Vision Dr.
Natick,  MA  01760 -2059
Correspondent Contact M. CHRISTINE MORGIDA
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Codes
OMC   ORT  
Date Received05/19/1995
Decision Date 01/16/1996
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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