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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 K012719
Device Name NAVIGUS II MR
Applicant
IMAGE-GUIDED NEUROLOGICS, INC.
2290 EAU GALLIE BLVD.
MELBOURNE,  FL  32935
Applicant Contact DAVID M LEE
Correspondent
IMAGE-GUIDED NEUROLOGICS, INC.
2290 EAU GALLIE BLVD.
MELBOURNE,  FL  32935
Correspondent Contact DAVID M LEE
Regulation Number882.4560
Classification Product Code
HAW  
Date Received08/14/2001
Decision Date 10/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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