The following data is part of a premarket notification filed by Imex Medical Systems, Inc. with the FDA for Imex Futuraldop Pro.
| Device ID | K970156 |
| 510k Number | K970156 |
| Device Name: | IMEX FUTURALDOP PRO |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | IMEX MEDICAL SYSTEMS, INC. 6355 JOYCE DR. Golden, CO 80403 |
| Contact | David W Wagner |
| Correspondent | David W Wagner IMEX MEDICAL SYSTEMS, INC. 6355 JOYCE DR. Golden, CO 80403 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-16 |
| Decision Date | 1997-04-04 |