The following data is part of a premarket notification filed by Suinsa with the FDA for Suinsa Diagnostic X-ray System.
| Device ID | K083109 |
| 510k Number | K083109 |
| Device Name: | SUINSA DIAGNOSTIC X-RAY SYSTEM |
| Classification | System, X-ray, Stationary |
| Applicant | SUINSA P.O. BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm SUINSA P.O. BOX 7007 Deerfield, IL 60015 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-20 |
| Decision Date | 2008-12-04 |
| Summary: | summary |