The following data is part of a premarket notification filed by Dilon Technologies, Inc. with the FDA for Dilon 2000, Model 2000-6x8 And Dilon 2000, Model 2000-5x5.
| Device ID | K984466 |
| 510k Number | K984466 |
| Device Name: | DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5 |
| Classification | Camera, Scintillation (gamma) |
| Applicant | DILON TECHNOLOGIES, INC. 12050 JEFFERSON AVE., SUITE 250 Newport News, VA 23606 |
| Contact | Lee H Fairchild |
| Correspondent | Lee H Fairchild DILON TECHNOLOGIES, INC. 12050 JEFFERSON AVE., SUITE 250 Newport News, VA 23606 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-16 |
| Decision Date | 1999-03-16 |
| Summary: | summary |