The following data is part of a premarket notification filed by Omega Medical Imaging, Inc. with the FDA for B-350 Ceiling Mounted C-positioner.
| Device ID | K970947 |
| 510k Number | K970947 |
| Device Name: | B-350 CEILING MOUNTED C-POSITIONER |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | OMEGA MEDICAL IMAGING, INC. 675 HICKMAN CIRCLE Sanford, FL 32771 |
| Contact | Douglas Coon |
| Correspondent | Douglas Coon OMEGA MEDICAL IMAGING, INC. 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 | 1997-03-14 |
| Decision Date | 1997-05-14 |
| Summary: | summary |