OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K010591
Device Name OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER
Original Applicant
OLYMPUS OPTICAL CO., LTD.
2951 ishikawa-cho
hachioji-shi
tokyo, 

JP

192-8507

Original Contact tsuyoshi yanai
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Code
KOG  
Date Received 02/28/2001
Decision Date 03/15/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party Yes

Combination Product

No