OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P


Device Classification Name

gastroscope and accessories, flexible/rigid

510(k) Number K021886
Device Name OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P
Original Applicant
OLYMPUS OPTICAL CO., LTD.
two corporate center dr.
melville, 
NY 
11747 -3157

Original Contact laura storms-tyler
Regulation Number 876.1500
Classification Product Code
FDS  
Subsequent Product Code
ITX  
Date Received 06/07/2002
Decision Date 06/19/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No