The following data is part of a premarket notification filed by Pentax Medical Of America, Inc with the FDA for Pentax Medical Video Colonoscope Ec34-i10t Series.
| Device ID | K180285 |
| 510k Number | K180285 |
| Device Name: | PENTAX Medical Video Colonoscope EC34-i10T Series |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | PENTAX Medical Of America, Inc 3 Paragon Drive Montvale, NJ 07645 -1782 |
| Contact | James W. Monroe |
| Correspondent | James W. Monroe PENTAX Medical Of America, Inc 3 Paragon Drive Montvale, NJ 07645 -1782 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-01 |
| Decision Date | 2018-10-26 |
| Summary: | summary |