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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Accessories, Image Post-Processing For Color Enhancement
510(k) Number K190805
Device Name PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL
Applicant
Pentax of America, Inc.
3 Paragon Dr.,
Montvale,  NJ  07645
Applicant Contact William Goeller
Correspondent
Namsa, Inc.
400 Hwy. 169 , Suite 500
Minneapolis,  MN  55426
Correspondent Contact Beryl St. Jeanne
Regulation Number876.1500
Classification Product Code
PEA  
Subsequent Product Codes
FDF   FDS  
Date Received03/29/2019
Decision Date 12/20/2019
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
Predetermined Change
Control Plan Authorized		 No
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