NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000


Device Classification Name

neurological stereotaxic instrument

510(k) Number K024201
Device Name NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000
Original Applicant
IMAGE-GUIDED NEUROLOGICS, INC.
2290 eau gallie blvd.
melbourne, 
FL 
32935

Original Contact david m lee
Regulation Number 882.4560
Classification Product Code
HAW  
Date Received 12/20/2002
Decision Date 03/12/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No