ENDOSCOPIC ULTRASOUND CENTER EU-Y0006


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K121564
Device Name ENDOSCOPIC ULTRASOUND CENTER EU-Y0006
Applicant
OLYMPUS MEDICAL SYSTEMS CORP.
3500 corporate parkway
p.o. box 610
center valley, 
PA 
18034 -0610

Applicant Contact laura storms-tyler
Correspondent
OLYMPUS MEDICAL SYSTEMS CORP.
3500 corporate parkway
p.o. box 610
center valley, 
PA 
18034 -0610

Correspodent Contact laura storms-tyler
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   KOG  
Date Received 05/29/2012
Decision Date 10/16/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No