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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Standard Polysomnograph With Electroencephalograph
510(k) Number K994142
Device Name GRASS TS3201/6401 EEG AMPLIFIER SYSTEM
Applicant
Grass Instrument Co.
570 Liberty St.
Braintree,  MA  02185
Applicant Contact STEPHEN E JOHNSON
Correspondent
Grass Instrument Co.
570 Liberty St.
Braintree,  MA  02185
Correspondent Contact STEPHEN E JOHNSON
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Code
GWQ  
Date Received12/08/1999
Decision Date 03/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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