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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 K932842
Device Name SPACELABS MEDICAL MODEL 90481 EEG MODULE
Applicant
Spacelabs Medical, Inc.
925 Sherman Ave.
Hamden,  CT  06514
Applicant Contact RAYMOND GIFFORD
Correspondent
Spacelabs Medical, Inc.
925 Sherman Ave.
Hamden,  CT  06514
Correspondent Contact RAYMOND GIFFORD
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received06/11/1993
Decision Date 03/02/1994
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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