PEDIGUARD NERVE DETECTOR SYSTEM


Device Classification Name

stimulator, electrical, evoked response

510(k) Number K030526
Device Name PEDIGUARD NERVE DETECTOR SYSTEM
Applicant
SPINEVISION, INC.
3003 summit blvd.
suite 1400
atlanta, 
GA 
30319

Applicant Contact lynnette whitaker
Correspondent
SPINEVISION, INC.
3003 summit blvd.
suite 1400
atlanta, 
GA 
30319

Correspodent Contact lynnette whitaker
Regulation Number 882.1870
Classification Product Code
GWF  
Date Received 02/19/2003
Decision Date 12/29/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No