The following data is part of a premarket notification filed by Kub Technologies, Inc with the FDA for Kubtec Xpert 20.
| Device ID | K083510 |
| 510k Number | K083510 |
| Device Name: | KUBTEC XPERT 20 |
| Classification | System, X-ray, Stationary |
| Applicant | KUB TECHNOLOGIES, INC 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Contact | Joseph M Azary |
| Correspondent | Joseph M Azary KUB TECHNOLOGIES, INC 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-26 |
| Decision Date | 2009-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B619X200 | K083510 | 000 |