The following data is part of a premarket notification filed by Advantage Medical Systems, Inc. with the FDA for Modified Fetal Monitor Model Fm-2.
| Device ID | K861556 |
| 510k Number | K861556 |
| Device Name: | MODIFIED FETAL MONITOR MODEL FM-2 |
| Classification | System, Monitoring, Perinatal |
| Applicant | ADVANTAGE MEDICAL SYSTEMS, INC. 925 SHERMAN AVE. Hamden, CT 06514 |
| Contact | Anthony Calderoni |
| Correspondent | Anthony Calderoni ADVANTAGE MEDICAL SYSTEMS, INC. 925 SHERMAN AVE. Hamden, CT 06514 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-25 |
| Decision Date | 1986-07-07 |