The following data is part of a premarket notification filed by Pentax Of America, Inc. with the FDA for Pentax Eg-3670urk Ultrasound Video Gastroscope + Hi Vision Preirus.
| Device ID | K130206 |
| 510k Number | K130206 |
| Device Name: | PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS |
| Classification | Endoscopic Ultrasound System, Gastroenterology-urology |
| Applicant | PENTAX OF AMERICA, INC. 3 PARAGON DR. Montvale, NJ 07645 -1782 |
| Contact | Krishna Govindarajan |
| Correspondent | Krishna Govindarajan PENTAX OF AMERICA, INC. 3 PARAGON DR. 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 | 2013-01-28 |
| Decision Date | 2013-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333232550 | K130206 | 000 |
| 04961333228362 | K130206 | 000 |
| 04961333123339 | K130206 | 000 |
| 04961333123322 | K130206 | 000 |
| 04961333123315 | K130206 | 000 |
| 04961333082674 | K130206 | 000 |
| 04961333123230 | K130206 | 000 |
| 04961333123223 | K130206 | 000 |
| 04961333123216 | K130206 | 000 |