GIVEN DIAGNOSTICS SYSTEM


Device Classification Name

system, imaging, gastrointestinal, wireless, capsule

510(k) Number K022362
Device Name GIVEN DIAGNOSTICS SYSTEM
Original Applicant
GIVEN IMAGING LTD.
new industrial park
p.o. box 258
yoqneam, 

IL

20692

Original Contact shoshana friedman
Regulation Number 876.1300
Classification Product Code
NEZ  
Date Received 07/22/2002
Decision Date 08/09/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No