The following data is part of a premarket notification filed by Forum Engineering Technologies (96) Ltd. with the FDA for Bingo Pro.
| Device ID | K111474 |
| 510k Number | K111474 |
| Device Name: | BINGO PRO |
| Classification | Locator, Root Apex |
| Applicant | FORUM ENGINEERING TECHNOLOGIES (96) LTD. 1 PLATIN ST. NEW INDUSTRIAL ZONE Rishon Lezion, IL 75653 |
| Contact | Yuliya Yutkevich |
| Correspondent | Yuliya Yutkevich FORUM ENGINEERING TECHNOLOGIES (96) LTD. 1 PLATIN ST. NEW INDUSTRIAL ZONE Rishon Lezion, IL 75653 |
| Product Code | LQY |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-27 |
| Decision Date | 2011-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290114351102 | K111474 | 000 |
| 07290114351003 | K111474 | 000 |