The following data is part of a premarket notification filed by Pentax Of America, Inc. with the FDA for Pentax Medical Ultrasound Upper Gi Video Scope Eg34-j10u, Pentax Medical Ultrasound Upper Gi Video Scope Eg36-j10ur, Pentax Medical Ultrasound Upper Gi Video Scope Eg38-j10ut, Pentax Medical Ultrasound Video Bronchoscope Eb19-j10u.
| Device ID | K203166 |
| 510k Number | K203166 |
| Device Name: | PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U |
| Classification | Endoscopic Ultrasound System, Gastroenterology-urology |
| Applicant | PENTAX Of America, Inc. 3 Paragon Drive Montvale, NJ 07645 -1782 |
| Contact | William Goeller |
| Correspondent | Fumiaki Kanai MIC International 4-1-17 Hongo Bunkyo-ku, JP 113-0033 |
| Product Code | ODG |
| Subsequent Product Code | EOQ |
| Subsequent Product Code | ITX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-23 |
| Decision Date | 2020-12-30 |