The following data is part of a premarket notification filed by Omega Medical Imaging, Inc. with the FDA for Model B-200 C-arm & Model C-300 Cardiac Table.
| Device ID | K902005 |
| 510k Number | K902005 |
| Device Name: | MODEL B-200 C-ARM & MODEL C-300 CARDIAC TABLE |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | OMEGA MEDICAL IMAGING, INC. 671 HICKMAN CIRCLE Sanford, FL 32771 |
| Contact | Robert C Lindquist |
| Correspondent | Robert C Lindquist OMEGA MEDICAL IMAGING, INC. 671 HICKMAN CIRCLE Sanford, FL 32771 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-04 |
| Decision Date | 1990-09-20 |