The following data is part of a premarket notification filed by Erchonia Medical, Inc. with the FDA for Erchonia Ioto_240.
| Device ID | K062792 |
| 510k Number | K062792 |
| Device Name: | ERCHONIA IOTO_240 |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | ERCHONIA MEDICAL, INC. 13 RED FOX LANE Littleton, CO 80127 |
| Contact | Kevin Walls,rac |
| Correspondent | Kevin Walls,rac ERCHONIA MEDICAL, INC. 13 RED FOX LANE Littleton, CO 80127 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-18 |
| Decision Date | 2007-03-01 |