The following data is part of a premarket notification filed by Imex Medical Systems, Inc. with the FDA for Imex Dop-tone Ii.
| Device ID | K901593 |
| 510k Number | K901593 |
| Device Name: | IMEX DOP-TONE II |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | IMEX MEDICAL SYSTEMS, INC. 6355 JOYCE DR. Golden, CO 80403 |
| Contact | Ed Bistrick |
| Correspondent | Ed Bistrick IMEX MEDICAL SYSTEMS, INC. 6355 JOYCE DR. Golden, CO 80403 |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-05 |
| Decision Date | 1990-07-02 |