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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K871338
Device Name NOVAMETRIX MODEL 200 MAGSTIM
Applicant
Novametrix Medical Systems, Inc.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Applicant Contact JAMES R VEALE
Correspondent
Novametrix Medical Systems, Inc.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Correspondent Contact JAMES R VEALE
Regulation Number882.1870
Classification Product Code
GWF  
Date Received04/03/1987
Decision Date 08/04/1987
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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