The following data is part of a premarket notification filed by Ralco S.r.l. with the FDA for Model R605dasm Automatic X-ray Collimator.
| Device ID | K083029 |
| 510k Number | K083029 |
| Device Name: | MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR |
| Classification | Collimator, Automatic, Radiographic |
| Applicant | RALCO S.R.L. P.O. BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm RALCO S.R.L. P.O. BOX 7007 Deerfield, IL 60015 |
| Product Code | IZW |
| CFR Regulation Number | 892.1610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-10 |
| Decision Date | 2008-12-05 |
| Summary: | summary |