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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 K024192
Device Name VECTORVISION FLUORO3D
Applicant
Brainlab AG
Ammerthalstrasse 8
Heimstetten,  DE 85551
Applicant Contact RAINER BIRKENBACH
Correspondent
Brainlab AG
Ammerthalstrasse 8
Heimstetten,  DE 85551
Correspondent Contact RAINER BIRKENBACH
Regulation Number882.4560
Classification Product Code
HAW  
Date Received11/20/2002
Decision Date 06/11/2003
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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