The following data is part of a premarket notification filed by Omega Medical Imaging, Llc with the FDA for Cs-series-fp With 3030+option.
| Device ID | K121293 |
| 510k Number | K121293 |
| Device Name: | CS-SERIES-FP WITH 3030+OPTION |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | OMEGA MEDICAL IMAGING, LLC 675 HICKMAN CIRCLE Sanford, FL 32771 |
| Contact | Brian J Fleming |
| Correspondent | Brian J Fleming OMEGA MEDICAL IMAGING, LLC 675 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 | 2012-04-30 |
| Decision Date | 2012-07-26 |
| Summary: | summary |