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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 K042391
Device Name KOLIBRI IMAGE GUIDED SURGERY SYSTEM
Applicant
BRAINLAB AG
AMMERTHALSTRASSE 8
HEIMSTETTEN,  DE 85551
Applicant Contact JENS WITTE
Correspondent
BRAINLAB AG
AMMERTHALSTRASSE 8
HEIMSTETTEN,  DE 85551
Correspondent Contact JENS WITTE
Regulation Number882.4560
Classification Product Code
HAW  
Date Received09/02/2004
Decision Date 10/19/2004
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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