The following data is part of a premarket notification filed by Axiom Usa. Inc with the FDA for Drx3000.
| Device ID | K022602 |
| 510k Number | K022602 |
| Device Name: | DRX3000 |
| Classification | Equipment, Traction, Powered |
| Applicant | AXIOM USA. INC 3830 GUNN HWY Tampa, FL 33624 |
| Contact | Jim Gibson |
| Correspondent | Jim Gibson AXIOM USA. INC 3830 GUNN HWY Tampa, FL 33624 |
| Product Code | ITH |
| CFR Regulation Number | 890.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-06 |
| Decision Date | 2003-01-23 |
| Summary: | summary |