The following data is part of a premarket notification filed by Villa Sistemi Medicali S.p.a. with the FDA for Drf 4343.
| Device ID | K080859 |
| 510k Number | K080859 |
| Device Name: | DRF 4343 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | VILLA SISTEMI MEDICALI S.P.A. VIA DELLE AZALEE 3 Buccinasco, IT 20090 |
| Contact | Paolo C Santin |
| Correspondent | Paolo C Santin VILLA SISTEMI MEDICALI S.P.A. VIA DELLE AZALEE 3 Buccinasco, IT 20090 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-27 |
| Decision Date | 2008-06-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08057737122361 | K080859 | 000 |
| 08057737122262 | K080859 | 000 |
| 08057737122217 | K080859 | 000 |