FULCRUM


Device Classification Name

digitizer, image, radiological

510(k) Number K021949
Device Name FULCRUM
Original Applicant
HOWTEK, INC.
21 park ave.
hudson, 
NH 
03051

Original Contact john e rosenstengel
Regulation Number 892.2030
Classification Product Code
LMA  
Date Received 06/13/2002
Decision Date 08/12/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No