The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Counterpoise System.
| Device ID | K944983 |
| 510k Number | K944983 |
| Device Name: | MEDRAD COUNTERPOISE SYSTEM |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | MEDRAD, INC. 271 KAPPA DR. Pittsburgh, PA 15238 -2870 |
| Contact | Jan Dobscha |
| Correspondent | Jan Dobscha MEDRAD, INC. 271 KAPPA DR. Pittsburgh, PA 15238 -2870 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-11 |
| Decision Date | 1994-11-29 |