The following data is part of a premarket notification filed by Imex Medical Systems, Inc. with the FDA for Vascular Recorder #301.
| Device ID | K832369 |
| 510k Number | K832369 |
| Device Name: | VASCULAR RECORDER #301 |
| Classification | Transducer, Ultrasonic |
| Applicant | IMEX MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JOP |
| CFR Regulation Number | 870.2880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-15 |
| Decision Date | 1984-03-12 |