The following data is part of a premarket notification filed by Pentax Of America, Inc. with the FDA for Pentax Medical Endoscopic Ultrasound System.
| Device ID | K182004 |
| 510k Number | K182004 |
| Device Name: | PENTAX Medical Endoscopic Ultrasound System |
| Classification | Endoscopic Ultrasound System, Gastroenterology-urology |
| 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 | ODG |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-27 |
| Decision Date | 2018-08-21 |
| Summary: | summary |