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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source Localization Software For Electroencephalograph Or Magnetoencephalograph
510(k) Number K941553
Device Name MAGNES II BIOMAGNETOMETER
Applicant
BIOMAGNETIC TECHNOLOGIES, INC.
9727 PACIFIC HEIGHTS BLVD.
SAN DIEGO,  CA  92121 -3719
Applicant Contact EUGENE C HIRSCHKOFF
Correspondent
BIOMAGNETIC TECHNOLOGIES, INC.
9727 PACIFIC HEIGHTS BLVD.
SAN DIEGO,  CA  92121 -3719
Correspondent Contact EUGENE C HIRSCHKOFF
Regulation Number882.1400
Classification Product Code
OLX  
Subsequent Product Codes
GWF   GWQ   OLY  
Date Received03/30/1994
Decision Date 05/16/1996
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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