The following data is part of a premarket notification filed by Pentax Of America, Inc. with the FDA for Pentax Epk-i5020 Video Processor.
Device ID | K113873 |
510k Number | K113873 |
Device Name: | PENTAX EPK-I5020 VIDEO PROCESSOR |
Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
Applicant | PENTAX OF AMERICA, INC. 1129 BLOOMFIELD AVENUE West Caldwell, NJ 07006 |
Contact | Robert Schiff |
Correspondent | Robert Schiff PENTAX OF AMERICA, INC. 1129 BLOOMFIELD AVENUE West Caldwell, NJ 07006 |
Product Code | FET |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-12-30 |
Decision Date | 2012-06-22 |
Summary: | summary |