The following data is part of a premarket notification filed by Pentax Of America, Inc. with the FDA for Pentax Medical Epk-i7010 And Pentax Epk-i5010 Video Processors With Gi Family.
| Device ID | K191282 |
| 510k Number | K191282 |
| Device Name: | PENTAX Medical EPK-i7010 And PENTAX EPK-i5010 Video Processors With GI Family |
| Classification | Endoscope, Accessories, Image Post-processing For Color Enhancement |
| Applicant | PENTAX Of America, Inc. 3 Paragon Drive Montvale, NJ 07645 -1782 |
| Contact | William Goeller |
| Correspondent | William Goeller PENTAX Of America, Inc. 3 Paragon Drive Montvale, NJ 07645 -1782 |
| Product Code | PEA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-13 |
| Decision Date | 2019-11-08 |