FUJINON ULTRASONIC PROCESSOR


Device Classification Name

gastroscope and accessories, flexible/rigid

510(k) Number K111243
Device Name FUJINON ULTRASONIC PROCESSOR
Applicant
FUJINON INC.
419 west avenue
stamford, 
CT 
06902

Applicant Contact katherine y choi
Regulation Number 876.1500
Classification Product Code
FDS  
Subsequent Product Codes
ITX   IYN   IYO  
Date Received 05/03/2011
Decision Date 05/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party Yes

Combination Product

No