MIROCAM CAPSULE ENDOSCOPE SYSTEM


Device Classification Name

system, imaging, gastrointestinal, wireless, capsule

510(k) Number K111450
Device Name MIROCAM CAPSULE ENDOSCOPE SYSTEM
Applicant
INTROMEDIC CO., LTD
40 plain street
north attleboro, 
MA 
02760

Applicant Contact jeffrey roberts
Correspondent
INTROMEDIC CO., LTD
40 plain street
north attleboro, 
MA 
02760

Correspodent Contact jeffrey roberts
Regulation Number 876.1300
Classification Product Code
NEZ  
Date Received 05/25/2011
Decision Date 05/18/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Clinical Trials NCT00878982
Reviewed by Third Party No

Combination Product

No