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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 K971329
Device Name CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM)
Applicant
CTF SYSTEMS, INC.
15-1750 MCLEAN AVE.
PORT COQUITLAM, B.C.,  CA V3C 1M9
Applicant Contact STEPHEN E ROBINSON
Correspondent
CTF SYSTEMS, INC.
15-1750 MCLEAN AVE.
PORT COQUITLAM, B.C.,  CA V3C 1M9
Correspondent Contact STEPHEN E ROBINSON
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Code
OLY  
Date Received04/10/1997
Decision Date 11/20/1997
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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