The following data is part of a premarket notification filed by Pentax Medical with the FDA for Pentax Medical Ed-3490tk Video Duodenoscope.
| Device ID | K192280 |
| 510k Number | K192280 |
| Device Name: | PENTAX Medical ED-3490TK Video Duodenoscope |
| Classification | Duodenoscope And Accessories, Flexible/rigid |
| Applicant | Pentax Medical 3 Paragon Drive Montvale, NJ 07645 |
| Contact | William Goeller |
| Correspondent | William Goeller Pentax Medical 3 Paragon Drive Montvale, NJ 07645 |
| Product Code | FDT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-22 |
| Decision Date | 2019-10-21 |
| Summary: | summary |