The following data is part of a premarket notification filed by Danish Diagnostic Development A/s with the FDA for Cardiocam Model 9csy0799.
| Device ID | K011611 |
| 510k Number | K011611 |
| Device Name: | CARDIOCAM MODEL 9CSY0799 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | DANISH DIAGNOSTIC DEVELOPMENT A/S DR. NEERGAARDSVEJ 5F 2970 Horshom, DK 2970 |
| Contact | Niels S Orensen |
| Correspondent | Pamela K Gwynn 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 | 2001-05-25 |
| Decision Date | 2001-06-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05711665002012 | K011611 | 000 |
| 05711665002006 | K011611 | 000 |
| 05711665002005 | K011611 | 000 |