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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 K993708
Device Name BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG
Applicant
Biomagnetic Technologies, Inc.
9727 Pacific Heights Blvd.
San Diego,  CA  92121
Applicant Contact EUGENE C HIRSCHKOFF
Correspondent
Biomagnetic Technologies, Inc.
9727 Pacific Heights Blvd.
San Diego,  CA  92121
Correspondent Contact EUGENE C HIRSCHKOFF
Regulation Number882.1400
Classification Product Code
OLX  
Subsequent Product Codes
GWQ   OLY  
Date Received11/03/1999
Decision Date 12/03/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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