The following data is part of a premarket notification filed by Advantage Medical Systems, Inc. with the FDA for Model Im77 Intrapartum Fetal Monitor (modification).
| Device ID | K955931 |
| 510k Number | K955931 |
| Device Name: | MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION) |
| 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 | 1995-12-15 |
| Decision Date | 1996-08-14 |