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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
Predetermined Change
Control Plan Authorized		 No
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