MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM


Device Classification Name

system, imaging, gastrointestinal, wireless, capsule

510(k) Number K022980
Device Name MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
Original Applicant
GIVEN IMAGING LTD.
new industrial park
p.o. box 258
yoqneam, 

IL

20692

Original Contact shoshana (shos) friedman
Regulation Number 876.1300
Classification Product Code
NEZ  
Date Received 09/09/2002
Decision Date 02/27/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No