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 |