The following data is part of a premarket notification filed by Pentax Of America, Inc. with the FDA for Pentax Medical Endoscopic Ultrasound System, Eg-3270uk Upper G.i. Video Scope (convex Array Type) With Epk-i5010 Video Processor And Hi Vision Preirus Ultrasound Scanner.
| Device ID | K162447 |
| 510k Number | K162447 |
| Device Name: | PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) With EPK-i5010 Video Processor And HI VISION Preirus Ultrasound Scanner |
| Classification | Endoscopic Ultrasound System, Gastroenterology-urology |
| Applicant | PENTAX Of America, Inc. 3 Paragon Drive Montvale, NJ 07645 -1782 |
| Contact | Krishna Govindarajan |
| Correspondent | Krishna Govindarajan 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 | 2016-09-01 |
| Decision Date | 2017-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333233953 | K162447 | 000 |
| 04961333233793 | K162447 | 000 |
| 84961333253926 | K162447 | 000 |
| 04961333127184 | K162447 | 000 |