The following data is part of a premarket notification filed by Ralco S.r.l. with the FDA for R 72.
| Device ID | K030487 |
| 510k Number | K030487 |
| Device Name: | R 72 |
| Classification | Device, Beam Limiting, X-ray, Diagnostic |
| Applicant | RALCO S.R.L. 333 MILFORD ROAD Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm RALCO S.R.L. 333 MILFORD ROAD Deerfield, IL 60015 |
| Product Code | KPW |
| CFR Regulation Number | 892.1610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-14 |
| Decision Date | 2003-08-01 |
| Summary: | summary |