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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Mechanical, Evoked Response
510(k) Number K913604
Device Name SOMATOSENSORY STIMULUS SYSTEM
Applicant
Biomagnetic Technologies, Inc.
9727 Pacific Heights Blvd.
San Diego,  CA  92121
Applicant Contact GERALD S PALECKI
Correspondent
Biomagnetic Technologies, Inc.
9727 Pacific Heights Blvd.
San Diego,  CA  92121
Correspondent Contact GERALD S PALECKI
Regulation Number882.1880
Classification Product Code
GZP  
Date Received08/14/1991
Decision Date 12/09/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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