The following data is part of a premarket notification filed by Pentax Of America, Inc. with the FDA for Pentax Medical Eg-j10u Endoscopic Ultrasound System - Eg34-j10u Ultrasound Upper Gi Video Scope (convex Array Type), Eg36-j10ur Ultrasound Upper Gi Video Scope (radial Array Type), Eg38-j10ut Ultrasound Upper Gi Video Scope (convex Array Type).
| Device ID | K200090 |
| 510k Number | K200090 |
| Device Name: | PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type) |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-16 |
| Decision Date | 2020-07-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333248988 | K200090 | 000 |
| 04961333248902 | K200090 | 000 |
| 04961333248827 | K200090 | 000 |
| 04961333239429 | K200090 | 000 |
| 04961333239399 | K200090 | 000 |
| 04961333230709 | K200090 | 000 |