The following data is part of a premarket notification filed by Mindchild Medical with the FDA for Meridian M110 Fetal Monitoring System.
| Device ID | K161902 |
| 510k Number | K161902 |
| Device Name: | Meridian M110 Fetal Monitoring System |
| Classification | System, Monitoring, Perinatal |
| Applicant | MINDCHILD MEDICAL 1600 OSGOOD STREET #2-17 North Andover, MA 01845 |
| Contact | Jim Robertson |
| Correspondent | Leo Basta NORTHSTAR BIOMEDICAL ASSOCIATES 93 BENEFIT STREET Providence, RI 02904 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-11 |
| Decision Date | 2017-01-12 |