The following data is part of a premarket notification filed by Imex Medical Systems, Inc. with the FDA for Imex 8000 Personal Cascular Lab.
| Device ID | K942243 |
| 510k Number | K942243 |
| Device Name: | IMEX 8000 PERSONAL CASCULAR LAB |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | IMEX MEDICAL SYSTEMS, INC. 6355 JOYCE DR. Golden, CO 80403 |
| Contact | Dennis Newman |
| Correspondent | Dennis Newman 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 | 1994-05-09 |
| Decision Date | 1995-11-03 |