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 |