The following data is part of a premarket notification filed by Pentax Medical Of America, Inc with the FDA for Pentax Video Upper G.i. Scope Eg34-i10.
| Device ID | K180292 |
| 510k Number | K180292 |
| Device Name: | PENTAX Video Upper G.I. Scope EG34-i10 |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| Applicant | PENTAX Medical Of America, Inc 3 Paragon Drive Montvale, NJ 07645 -1782 |
| Contact | James W. Monroe |
| Correspondent | James W. Monroe PENTAX Medical Of America, Inc 3 Paragon Drive Montvale, NJ 07645 -1782 |
| Product Code | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-01 |
| Decision Date | 2018-10-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333233991 | K180292 | 000 |