The following data is part of a premarket notification filed by Danish Diagnostic Development A/s with the FDA for C.cam-ac.
| Device ID | K051460 |
| 510k Number | K051460 |
| Device Name: | C.CAM-AC |
| Classification | System, Tomography, Computed, Emission |
| Applicant | DANISH DIAGNOSTIC DEVELOPMENT A/S DR. NEERGAARDSVEJ 5F Horsholm, DK |
| Contact | Niels Sorensen |
| Correspondent | Jeffrey D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-06-03 |
| Decision Date | 2005-06-15 |
| Summary: | summary |