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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Magnetoencephalograph
510(k) Number K962317
Device Name MAGNES 2500 WH BIOMAGNETOMETER
Applicant
BIOMAGNETIC TECHNOLOGIES, INC.
9727 PACIFIC HEIGHTS BLVD.
SAN DIEGO,  CA  92121 -3719
Applicant Contact EUGENE C HIRSCHKOFF, PH.D.
Correspondent
BIOMAGNETIC TECHNOLOGIES, INC.
9727 PACIFIC HEIGHTS BLVD.
SAN DIEGO,  CA  92121 -3719
Correspondent Contact EUGENE C HIRSCHKOFF, PH.D.
Regulation Number882.1400
Classification Product Code
OLY  
Date Received06/17/1996
Decision Date 05/07/1997
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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