The following data is part of a premarket notification filed by Dorex, Inc. with the FDA for Dorex Spectrum 9000mb Thermography System.
| Device ID | K023434 |
| 510k Number | K023434 |
| Device Name: | DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM |
| Classification | System, Telethermographic (adjunctive Use) |
| Applicant | DOREX, INC. 954 NORTH LEMON ST. Orange, CA 92867 |
| Contact | Mel Kutas |
| Correspondent | Mel Kutas DOREX, INC. 954 NORTH LEMON ST. Orange, CA 92867 |
| Product Code | LHQ |
| CFR Regulation Number | 884.2980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-15 |
| Decision Date | 2002-11-14 |