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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 K031770
Device Name CI TKR/UKR
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 Received06/09/2003
Decision Date 08/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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