PENTAX EPK-I5010 VIDEO PROCESSOR


Device Classification Name

endoscope, accessories, image post-processing for color enhancement

510(k) Number K122470
Device Name PENTAX EPK-I5010 VIDEO PROCESSOR
Applicant
PENTAX MEDICAL
3 paragon drive
montvale, 
NJ 
07645

Applicant Contact krishna govindarajan
Correspondent
PENTAX MEDICAL
3 paragon drive
montvale, 
NJ 
07645

Correspodent Contact krishna govindarajan
Regulation Number 876.1500
Classification Product Code
PEA  
Date Received 08/13/2012
Decision Date 04/10/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No