The following data is part of a premarket notification filed by Oldelft Corp. Of America with the FDA for Simulix-mc Ct Extension.
| Device ID | K932848 |
| 510k Number | K932848 |
| Device Name: | SIMULIX-MC CT EXTENSION |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | OLDELFT CORP. OF AMERICA 2735 DORR AVE. Fairfax, VA 22031 |
| Contact | Sharon Bowling |
| Correspondent | Sharon Bowling OLDELFT CORP. OF AMERICA 2735 DORR AVE. Fairfax, VA 22031 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-10 |
| Decision Date | 1994-03-22 |