The following data is part of a premarket notification filed by Pentax Of America, Inc. with the FDA for Pentax Medical Video Upper Gi Scopes (eg Family), Pentax Medical Video Colonoscopes (ec Family).
| Device ID | K210485 |
| 510k Number | K210485 |
| Device Name: | PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family) |
| Classification | Gastroscope 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 | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-19 |
| Decision Date | 2021-05-13 |