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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
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