NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010


Device Classification Name

neurological stereotaxic instrument

510(k) Number K022100
Device Name NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010
Original Applicant
IMAGE-GUIDED NEUROLOGICS, INC.
2290 w. eau gallie blvd.
suite 210
melbourne, 
FL 
32935

Original Contact david m lee
Regulation Number 882.4560
Classification Product Code
HAW  
Date Received 06/28/2002
Decision Date 09/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls