The following data is part of a premarket notification filed by Pentax Medical Company with the FDA for Eg-3670urk.
| Device ID | K061068 |
| 510k Number | K061068 |
| Device Name: | EG-3670URK |
| Classification | Endoscopic Ultrasound System, Gastroenterology-urology |
| Applicant | PENTAX MEDICAL COMPANY 102 CHESTNUT RIDGE RD. Montvale, NJ 07645 -1856 |
| Contact | Paul Silva |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | ODG |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-04-17 |
| Decision Date | 2006-05-03 |
| Summary: | summary |