USG 2000SA


Device Classification Name

locator, intracorporeal device, ultrasonic, obstetric-gynecologic

510(k) Number K023227
Device Name USG 2000SA
Original Applicant
ULTRAGUIDE LTD.
377 route 17 south
hasbrouck heights, 
NJ 
07601

Original Contact george myers
Regulation Number 884.2225
Classification Product Code
HHJ  
Date Received 09/27/2002
Decision Date 10/22/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No