The following data is part of a premarket notification filed by Imex Medical Systems, Inc. with the FDA for Non Stress Test Monitor 507.
| Device ID | K840285 |
| 510k Number | K840285 |
| Device Name: | NON STRESS TEST MONITOR 507 |
| Classification | Cannula, Suction, Uterine |
| Applicant | IMEX MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HGH |
| CFR Regulation Number | 884.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-24 |
| Decision Date | 1984-05-09 |