The following data is part of a premarket notification filed by Iomed, Inc. with the FDA for Rh-950.
| Device ID | K033192 |
| 510k Number | K033192 |
| Device Name: | RH-950 |
| Classification | Device, Iontophoresis, Specific Uses |
| Applicant | IOMED, INC. 2441 SOUTH 3850 WEST, SUITE A Salt Lake City, UT 84120 -9941 |
| Contact | Curtis Jensen |
| Correspondent | Curtis Jensen IOMED, INC. 2441 SOUTH 3850 WEST, SUITE A Salt Lake City, UT 84120 -9941 |
| Product Code | KTB |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-10-02 |
| Decision Date | 2003-12-22 |
| Summary: | summary |