The following data is part of a premarket notification filed by Pentax Of America, Inc. with the FDA for Pentax Medical Epk-i7010 Video Processor With Gi Family.
| Device ID | K150618 |
| 510k Number | K150618 |
| Device Name: | PENTAX Medical EPK-i7010 Video Processor With GI Family |
| Classification | Endoscope, Accessories, Image Post-processing For Color Enhancement |
| Applicant | PENTAX OF AMERICA, INC. 3 PARAGON DRIVE Montvale, NJ 07645 |
| Contact | Krishna Govindarajan |
| Correspondent | Krishna Govindarajan PENTAX OF AMERICA, INC. 3 PARAGON DRIVE Montvale, NJ 07645 |
| Product Code | PEA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-10 |
| Decision Date | 2015-11-24 |
| Summary: | summary |