The following data is part of a premarket notification filed by Danish Diagnostic Development A/s with the FDA for Unicorn Model Sys0630.
| Device ID | K001888 |
| 510k Number | K001888 |
| Device Name: | UNICORN MODEL SYS0630 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | DANISH DIAGNOSTIC DEVELOPMENT A/S 2970 Horshom, DK 2970 |
| Contact | Neergaardsvej 5f |
| Correspondent | R. Kent Donohue UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2000-06-15 |
| Decision Date | 2000-06-30 |