The following data is part of a premarket notification filed by Pentax Of America, Inc. with the FDA for Pentax Eg-3870utk Ultrasound Video Gastroscope + Hi Vision Preirus.
| Device ID | K130247 |
| 510k Number | K130247 |
| Device Name: | PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS |
| Classification | Endoscopic Ultrasound System, Gastroenterology-urology |
| Applicant | PENTAX OF AMERICA, INC. 3 PARAGON DRIVE Montvale, NJ 07645 |
| Contact | Krishna Govindarajan |
| Correspondent | Krishna Govindarajan PENTAX OF AMERICA, INC. 3 PARAGON DRIVE Montvale, NJ 07645 |
| Product Code | ODG |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-01 |
| Decision Date | 2013-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333232567 | K130247 | 000 |
| 04961333228409 | K130247 | 000 |
| 04961333113545 | K130247 | 000 |
| 04961333123346 | K130247 | 000 |
| 04961333083138 | K130247 | 000 |