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 |