NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004


codes

Device Classification Name

neurological stereotaxic instrument

510(k) Number K002053
Device Name NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004
Original Applicant
ORTHOSOFT, INC.
80 queen st., suite 604
montreal, quebec, 

CA

h3c 2n5

Original Contact nicole landreville
Regulation Number 882.4560
Classification Product Code
HAW  
Date Received 07/06/2000
Decision Date 08/03/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

Type Special
Reviewed by Third Party No

Combination Product

No