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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 K992916
Device Name BRAINLAB STEREOTACTIC ARC
Applicant
Brainlab
100 Marine Pkwy.
Suite 305
Redwood City,  CA  94065
Applicant Contact ERIC LINDQUIST
Correspondent
Brainlab
100 Marine Pkwy.
Suite 305
Redwood City,  CA  94065
Correspondent Contact ERIC LINDQUIST
Regulation Number882.4560
Classification Product Code
HAW  
Date Received08/30/1999
Decision Date 01/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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