The following data is part of a premarket notification filed by Ralco S.r.l. with the FDA for R 302.
| Device ID | K946320 |
| 510k Number | K946320 |
| Device Name: | R 302 |
| Classification | Device, Beam Limiting, X-ray, Diagnostic |
| Applicant | RALCO S.R.L. VIA VOLTURNO, 29 20035 LISSONE MI Italy, IT 20035 |
| Contact | Vincenzo Velardii |
| Correspondent | Vincenzo Velardii RALCO S.R.L. VIA VOLTURNO, 29 20035 LISSONE MI Italy, IT 20035 |
| Product Code | KPW |
| CFR Regulation Number | 892.1610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-28 |
| Decision Date | 1995-05-11 |