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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 K910279
Device Name MCSEER/MICRO CONTROLLER SLD ST EEG EVENT RECORDER
Applicant
New England Medical Instruments, Inc.
10 Pheasant Ln.
Lexington,  MA  02173
Applicant Contact JOHN R IVES
Correspondent
New England Medical Instruments, Inc.
10 Pheasant Ln.
Lexington,  MA  02173
Correspondent Contact JOHN R IVES
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received01/23/1991
Decision Date 09/04/1991
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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