The following data is part of a premarket notification filed by Omega Medical Imaging, Inc. with the FDA for B-400 Ceiling Mounted Possitioner, Model B-400.
| Device ID | K990055 |
| 510k Number | K990055 |
| Device Name: | B-400 CEILING MOUNTED POSSITIONER, MODEL B-400 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | OMEGA MEDICAL IMAGING, INC. 675 HICKMAN CIRCLE Sanford, FL 32771 |
| Contact | Douglas M Coon |
| Correspondent | Douglas M 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 | 1999-01-07 |
| Decision Date | 1999-02-02 |
| Summary: | summary |