The following data is part of a premarket notification filed by Iomed, Inc. with the FDA for Transq3.
| Device ID | K001522 |
| 510k Number | K001522 |
| Device Name: | TRANSQ3 |
| Classification | Device, Iontophoresis, Specific Uses |
| Applicant | IOMED, INC. 3385 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Contact | W. Tim Miller |
| Correspondent | W. Tim Miller IOMED, INC. 3385 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Product Code | KTB |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-16 |
| Decision Date | 2000-10-18 |