The following data is part of a premarket notification filed by Pentax Of America, Inc. with the FDA for Pentax Medical Ed-3490tk, Video Duodenoscope, Pentax Medical Ed34-i10t, Video Duodenoscope.
| Device ID | K181522 |
| 510k Number | K181522 |
| Device Name: | PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope |
| Classification | Duodenoscope And Accessories, Flexible/rigid |
| 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 | FDT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-11 |
| Decision Date | 2018-07-09 |
| Summary: | summary |