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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 K901215
Device Name 700 SERIES BIOMAGNETOMETER
Applicant
BIOMAGNETIC TECHNOLOGIES, INC.
9727 PACIFIC HEIGHTS BLVD.
SAN DIEGO,  CA  92121 -3719
Applicant Contact GERALD S PALECKI
Correspondent
BIOMAGNETIC TECHNOLOGIES, INC.
9727 PACIFIC HEIGHTS BLVD.
SAN DIEGO,  CA  92121 -3719
Correspondent Contact GERALD S PALECKI
Regulation Number882.1400
Classification Product Code
OLX  
Subsequent Product Code
OLY  
Date Received03/14/1990
Decision Date 06/25/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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