ULTRAGUIDE CT-GUIDE 1010


codes

Device Classification Name

system, x-ray, tomography, computed

510(k) Number K002258
Device Name ULTRAGUIDE CT-GUIDE 1010
Original Applicant
ULTRAGUIDE LTD.
377 route 17 south
hasbrouck heights, 
NJ 
07601

Original Contact george myers
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 07/25/2000
Decision Date 08/08/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party Yes

Combination Product

No