The following data is part of a premarket notification filed by Pentax Medical with the FDA for Pentax Epk-i5010 Video Processor.
| Device ID | K122470 |
| 510k Number | K122470 |
| Device Name: | PENTAX EPK-I5010 VIDEO PROCESSOR |
| Classification | Endoscope, Accessories, Image Post-processing For Color Enhancement |
| Applicant | PENTAX MEDICAL 3 PARAGON DRIVE Montvale, NJ 07645 |
| Contact | Krishna Govindarajan |
| Correspondent | Krishna Govindarajan PENTAX MEDICAL 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 | 2012-08-13 |
| Decision Date | 2013-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333085453 | K122470 | 000 |
| 04961333169016 | K122470 | 000 |
| 04961333166435 | K122470 | 000 |
| 04961333132607 | K122470 | 000 |
| 04961333125845 | K122470 | 000 |
| 04961333083923 | K122470 | 000 |
| 04961333075348 | K122470 | 000 |