The following data is part of a premarket notification filed by Visaris D.o.o. Belgrade with the FDA for Visaris Avanse.
| Device ID | K150725 |
| 510k Number | K150725 |
| Device Name: | Visaris Avanse |
| Classification | System, X-ray, Stationary |
| Applicant | VISARIS D.o.o. Belgrade Batajnicki Drum 10 Deo 1b Zemun, RS 11080 |
| Contact | Milan Ratkovic |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-20 |
| Decision Date | 2015-06-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08606102809033 | K150725 | 000 |