EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE


Device Classification Name

endoscope and/or accessories

510(k) Number K021278
Device Name EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE
Original Applicant
PENTAX PRECISION INSTRUMENT CORP.
30 ramland rd.
orangeburg, 
NY 
10962

Original Contact paul silva
Regulation Number 876.1500
Classification Product Code
KOG  
Subsequent Product Code
ITX  
Date Received 04/22/2002
Decision Date 09/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No