The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Omniplane 300 System.
| Device ID | K883834 |
| 510k Number | K883834 |
| Device Name: | MEDRAD OMNIPLANE 300 SYSTEM |
| Classification | System, X-ray, Stationary |
| Applicant | MEDRAD, INC. RTE.910 MEDRAD DRIVE, P.O. BOX 780 Indianola, PA 15051 |
| Contact | Ruey C Dempsey |
| Correspondent | Ruey C Dempsey MEDRAD, INC. RTE.910 MEDRAD DRIVE, P.O. BOX 780 Indianola, PA 15051 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-09 |
| Decision Date | 1988-11-04 |