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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K012564
Device Name MODIFICATION TO: VECTORVISION FRAMELESS BIOPSY SYSTEM
Applicant
BRAINLAB AG
AMMERTHALSTRASSE 8
HEIMSTETTEN,  DE 85551
Applicant Contact STEFAN VILSMEIER
Correspondent
BRAINLAB AG
AMMERTHALSTRASSE 8
HEIMSTETTEN,  DE 85551
Correspondent Contact STEFAN VILSMEIER
Regulation Number882.4560
Classification Product Code
HAW  
Date Received08/09/2001
Decision Date 09/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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