The following data is part of a premarket notification filed by Advantage Medical Systems, Inc. with the FDA for Fetal Monitor Model Fhm-1.
| Device ID | K800013 |
| 510k Number | K800013 |
| Device Name: | FETAL MONITOR MODEL FHM-1 |
| Classification | System, Monitoring, Perinatal |
| Applicant | ADVANTAGE MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-01-04 |
| Decision Date | 1980-03-07 |