The following data is part of a premarket notification filed by Scanditronix, Inc. with the FDA for Dpd-3.
| Device ID | K942092 |
| 510k Number | K942092 |
| Device Name: | DPD-3 |
| Classification | Accelerator, Linear, Medical |
| Applicant | SCANDITRONIX, INC. HUSBYBORG, S-752 29 UPPSALA Sweden, SE |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-02 |
| Decision Date | 1994-07-29 |