The following data is part of a premarket notification filed by Imex Medical Systems, Inc. with the FDA for Imex Medical Systems, Inc. Imexlab 9100.
| Device ID | K973562 |
| 510k Number | K973562 |
| Device Name: | IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9100 |
| Classification | System, Imaging, Pulsed Doppler, 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 | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-19 |
| Decision Date | 1998-04-15 |